Halyard
12,802 catalogue numbers from VAOR024-03_0009, listed by Avid Medical, Inc., United States, under General Surgery Tray. 24 manufacturers in China are registered for this product code.
24manufacturers in China registered for this device type
12,802catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (11), Anhui (6), Zhejiang (4). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Changzhou Holymed Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Donghai Xingchen NON-Woven Products Co., Ltd. | North Donghai Development Zone, Lianyungang | Jiangsu | Contract manufacturer | 7 |
| Fengyang Jiehong Nonwoven Product Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 7 |
| 3A Medical Products Co., Ltd. | Liu An | Anhui | Contract manufacturer | 6 |
| Cobes Industries (Jinzhai) Co., Ltd. | Luan | Anhui | Contract manufacturer | 6 |
| Lianyungang Aiyeh Non-woven Products Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 6 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Showing 12 of 24. All 24 manufacturers in China registered for General Surgery Tray
Record
| Listed by | Avid Medical, Inc., United States |
|---|---|
| FDA product code | LRO |
| Device type | General Surgery Tray |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Premarket notification | Exempt |
| Record published | 2020-12-08 |
| Record revised | 2023-01-30 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: STORE AT ROOM TEMPERATURE |
| Packaging | Pack of 2, pack of 3, pack of 4, pack of 6, pack of 20, pack of 10 |
| Distribution end date | 2026-02-18 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VAOR024-03_0009 | In distribution | |
| BMHT014-04_0006 | In distribution | |
| HSAM007-09_0013 | In distribution | |
| KDAU201-01_0007 | In distribution | |
| AMMJ11AA_0003 | In distribution | |
| HHBP45-01_0004 | In distribution | |
| COPO63-01_0004 | In distribution | |
| DAGL72_0005 | In distribution | |
| GUMO40-01_0001 | In distribution | |
| SLTP20-02_0011 | In distribution | |
| VMCD019-05_0004 | In distribution | |
| SAMM015-15_0003 | In distribution | |
| LOUS006-08_0001 | In distribution | |
| SAMM017-18_0002 | In distribution | |
| MISS801_0012 | In distribution | |
| DAPB32_0001 | In distribution | |
| RYAH82-02_0014 | In distribution | |
| LIFE0090-12_0007 | In distribution | |
| OGAC25-01 | In distribution | |
| GBTJ22-01_0003 | In distribution | |
| ACEX18-03_0007 | In distribution | |
| MSPT504_0009 | In distribution | |
| CYMH104-02_0001 | In distribution | |
| FBCH113-01_0009 | In distribution | |
| WILF003-17_0021 | In distribution | |
| SFSGBSG41-01_0001 | In distribution | |
| JRPZ001-08_0006 | In distribution | |
| EUHM012-03_0004 | In distribution | |
| MHCV74-01_0003 | In distribution | |
| DGMJ33_0003 | In distribution | |
| DRSP53_0007 | In distribution | |
| AVMD011-01_0007 | In distribution | |
| SINA130-02_0007 | In distribution | |
| MEPK70E_0006 | In distribution | |
| SAMT109-09_0004 | In distribution | |
| BTMF011_0007 | In distribution | |
| NAPO0025-11_0009 | In distribution | |
| WRNM033-15_0003 | In distribution | |
| SJGH111-05_0004 | In distribution | |
| UFCF024-04_0004 | In distribution | |
| VARV054_0019 | In distribution | |
| SHAN431-05_0002 | In distribution | |
| ULKY013-06_0016 | In distribution | |
| ECAD006_0004 | In distribution | |
| WMHH213-04_0003 | In distribution | |
| SAMM025-02_0013 | In distribution | |
| JACK407-05_0004 | In distribution | |
| MHEC93-01_0001 | In distribution | |
| WRNM028-17_0001 | In distribution | |
| FTPO51-01_0004 | In distribution | |
| SHND418_0003 | In distribution | |
| SHAN442-02_0004 | In distribution | |
| LBEX34-01_0001 | In distribution | |
| WH0014-04_0010 | In distribution | |
| TSSC005-02_0013 | In distribution | |
| USAR032-13_0003 | In distribution | |
| VMCL036-08_0003 | In distribution | |
| HHTK38-01_0010 | In distribution | |
| SMHS027-06_0004 | In distribution | |
| WATN103-07_0004 | In distribution | |
| EUOR001-03_0003 | In distribution | |
| USAR028-19_0010 | In distribution | |
| SJGH110-02_0008 | In distribution | |
| EUOR001-05_0010 | In distribution | |
| JACK432-03_0001 | In distribution | |
| ONEL403-11_0001 | In distribution | |
| GLPP017_0006 | In distribution | |
| ESJH009-01_0001 | In distribution | |
| LCNW004-01_0001 | In distribution | |
| ECAD019_0002 | In distribution | |
| VAST019-05_0002 | In distribution | |
| RYST64-03_0008 | In distribution | |
| MMER001_0006 | In distribution | |
| VANA026-03_0002 | In distribution | |
| GBTA95-01_0001 | In distribution | |
| TOSC106-01_0004 | In distribution | |
| SFSSAMT100-13_0002 | In distribution | |
| JELE79-01_0003 | In distribution | |
| UDAA63-01_0001 | In distribution | |
| HNLP12-01_0001 | In distribution | |
| LAKC013-15_0002 | In distribution | |
| MEDF013-14_0001 | In distribution | |
| ESJH021_0006 | In distribution | |
| BMHT110-03_0001 | In distribution | |
| ACEN89-01_0006 | In distribution | |
| HEOR001-07_0010 | In distribution | |
| DRMN44_0011 | In distribution | |
| UFCF015-04_0004 | In distribution | |
| CFSS005-02_0011 | In distribution | |
| LLOG1000-15_0005 | In distribution | |
| VMCC024-08_0004 | In distribution | |
| FBCH111-04_0003 | In distribution | |
| ONEL410-02_0001 | In distribution | |
| BMHU007-02_0023 | In distribution | |
| VABH103-05_0004 | In distribution | |
| VANW012-01_0006 | In distribution | |
| MCLR804_0004 | In distribution | |
| ONEL1180-04_0002 | In distribution | |
| MMBF018-03_0004 | In distribution | |
| VAHT009-20_0002 | In distribution | |
| PSJH0015-01_0007 | In distribution | |
| KDAU226-02_0005 | In distribution | |
| KDAU235-02_0001 | In distribution | |
| SLTH18-01_0015 | In distribution | |
| NAHP007-04_0007 | In distribution | |
| WATN017-02_0004 | In distribution | |
| SAMM015-18_0002 | In distribution | |
| RYEX83-04_0013 | In distribution | |
| RDVA007-04_0006 | In distribution | |
| MSBM027-05_0001 | In distribution | |
| MMNP002-01_0008 | In distribution | |
| KDAU212-01_0006 | In distribution | |
| SELF110-06_0001 | In distribution | |
| WHEE033-26_0002 | In distribution | |
| WILF011-18_0011 | In distribution | |
| ECAD014-02_0011 | In distribution | |
| SUSG30-02_0003 | In distribution | |
| LIFE0242_0018 | In distribution | |
| URLA001-02_0002 | In distribution | |
| UCMC001-08_0008 | In distribution | |
| NAMC423-08_0015 | In distribution | |
| BLPP21J_0002 | In distribution | |
| HHLE11-01_0001 | In distribution | |
| DRSB84-01_0002 | In distribution | |
| ESKA32-01_0007 | In distribution | |
| JEFU001-01_0005 | In distribution | |
| SAAN71V_0007 | In distribution | |
| SHAN436-02_0004 | In distribution | |
| SHRS002-03_0003 | In distribution | |
| WAFB231_0007 | In distribution | |
| SAOR89AD_0003 | In distribution | |
| ASKN23-02_0004 | In distribution | |
| BHLE58H_0001 | In distribution | |
| BHCA01J_0001 | In distribution | |
| EURO045_0006 | In distribution | |
| VAML015-10_0002 | In distribution | |
| MMBR005-01_0015 | In distribution | |
| PLTC002-10_0008 | In distribution | |
| RYTR38-05_0003 | In distribution | |
| VHWV014-04_0006 | In distribution | |
| SINA248_0005 | In distribution | |
| VAIC021-08_0002 | In distribution | |
| LIFE0234-02_0006 | In distribution | |
| VAPX018-08_0006 | In distribution | |
| LBCS58-01_0001 | In distribution | |
| WRNM046-09_0001 | In distribution | |
| DUTC93_0005 | In distribution | |
| MSBM036-04_0003 | In distribution | |
| HADH002-03_0004 | In distribution | |
| SAMT110-09_0002 | In distribution | |
| JCLC12F_0007 | In distribution | |
| BUAH037-05_0004 | In distribution | |
| MEOR10S_0005 | In distribution | |
| VHWV002-13_0004 | In distribution | |
| RYSA36-06_0001 | In distribution | |
| RYTP12-03_0007 | In distribution | |
| COGN81-01_0005 | In distribution | |
| JDLP79-03_0003 | In distribution | |
| UMIA126-01_0003 | In distribution | |
| NHPF014-03_0004 | In distribution | |
| LIFE0097-03_0002 | In distribution | |
| SHSD009-01_0004 | In distribution | |
| VAML037-03_0004 | In distribution | |
| VCPW013-02_0004 | In distribution | |
| VAHT040-02_0003 | In distribution | |
| UMIA103-02_0005 | In distribution | |
| BLKN16K_0004 | In distribution | |
| RYPU47-03_0017 | In distribution | |
| SHAN438-04_0012 | In distribution | |
| WRNM051-14_0003 | In distribution | |
| LIFE0216-06_0001 | In distribution | |
| LIFE0220-01_0001 | In distribution | |
| LIFE0062-04_0001 | In distribution | |
| SHAN441-03_0002 | In distribution | |
| MISS800_0009 | In distribution | |
| MDHD38SAMP_0001 | In distribution | |
| DAAU12_0006 | In distribution | |
| SHAN417-02_0002 | In distribution | |
| KDAU235-01_0013 | In distribution | |
| VANW007-02_0008 | In distribution | |
| BKSU51_0008 | In distribution | |
| LIFE0242-01_0003 | In distribution | |
| RDLD025-07_0006 | In distribution | |
| VCIH010-03_0006 | In distribution | |
| WMCW044-01_0005 | In distribution | |
| CEMC800-01_0005 | In distribution | |
| KRLP33-01_0001 | In distribution | |
| SARO64N_0004 | In distribution | |
| NHPF015-01_0010 | In distribution | |
| TPSP14-01_0003 | In distribution | |
| MHHY51-01_0003 | In distribution | |
| KDAU229-01_0005 | In distribution | |
| VAHT009-14_0006 | In distribution | |
| BMHU005-02_0008 | In distribution | |
| WHVA005-07_0005 | In distribution | |
| VCIH007-06_0010 | In distribution | |
| NCDS019-04_0005 | In distribution | |
| VMCD018-11_0001 | In distribution | |
| FHTU33S_0001 | In distribution | |
| HSAM029-05_0002 | In distribution | |
| LAKC014-09_0001 | In distribution | |
| MSBM032-04_0003 | In distribution | |
| MMOK016-05_0009 | In distribution | |
| EAMC117-11_0006 | In distribution | |
| MAMC222-16_0001 | In distribution | |
| BAAK105-12_0005 | In distribution | |
| BUAH020-09_0013 | In distribution | |
| QPMN13-01_0006 | In distribution | |
| JACK404-03_0002 | In distribution | |
| SHAN425-01_0004 | In distribution | |
| GBAS002-08_0001 | In distribution | |
| FBCH132-01_0006 | In distribution | |
| VMCC019-13_0002 | In distribution | |
| WUAS03-01_0004 | In distribution | |
| RYPL32-05_0001 | In distribution | |
| VMCL022-09_0005 | In distribution | |
| EUHB006-01_0003 | In distribution | |
| SFSHOHP28-01_0002 | In distribution | |
| VAOR021-06_0005 | In distribution | |
| APEC001-05_0005 | In distribution | |
| LAKC019-09_0002 | In distribution | |
| LAKN05AD_0010 | In distribution | |
| RDLD013-06_0009 | In distribution | |
| BMHT013-05_0011 | In distribution | |
| VMCD019-10_0001 | In distribution | |
| RNHS001-02_0007 | In distribution | |
| SHND403-01_0002 | In distribution | |
| LIFE0241-01_0001 | In distribution | |
| CCEN15-01_0001 | In distribution | |
| RYTR38-06_0001 | In distribution | |
| MHCV93-01_0007 | In distribution | |
| MMBF026_0007 | In distribution | |
| RYAL84-04_0003 | In distribution | |
| BJAC010-09_0002 | In distribution | |
| NAMC077-02_0006 | In distribution | |
| SFSEVCY19-01_0001 | In distribution | |
| MAMC215-13_0005 | In distribution | |
| SAMM110-03_0001 | In distribution | |
| WRNM038-10_0002 | In distribution | |
| RYSN67-02_0020 | In distribution | |
| WRNM028-14_0005 | In distribution | |
| SELF117-04_0003 | In distribution | |
| BUAH029-03_0007 | In distribution | |
| FBCH115-04_0006 | In distribution | |
| DNAZ007-07_0001 | In distribution | |
| UNTJ94-02_0005 | In distribution | |
| MHLC010SAMP_0001 | In distribution | |
| MMTN004-01_0003 | In distribution | |
| WRNM023-14_0006 | In distribution | |
| BMGT015-03_0003 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 67,931 |
| Medline Industries, Inc. | Medline Industries, Inc. | 54,362 |
| Avid TruCustom | Avid Medical, Inc. | 13,498 |
| ACS | American Contract Systems, Inc. | 10,337 |
| SurgiTrack | Owens & Minor Distribution, Inc. | 5,575 |
| Aligned Medical Solutions | Aligned Medical Solutions | 3,490 |
| SurgiTrackSM | Owens & Minor Distribution, Inc. | 3,364 |
| DeRoyal | Deroyal Industries, Inc. | 2,770 |
| Medline | Medline Industries, Inc. | 1,960 |
| Henry Schein | Henry Schein, Inc. | 729 |
| Stradis | Stradis Healthcare | 685 |
| Centurion | Centurion Medical Products Corporation | 672 |
Showing 12 of 113. All products under General Surgery Tray
Recalls Naming This Product
73 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2026-08-10 | Not classified | Nonconforming Material/Component | Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical. | 240 kits |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2026-07-14 | Not classified | Packaging process control | Convenience kits contain BD ChloraPrep Clear – 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides | 288 units |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2026-07-14 | Not classified | Packaging process control | Convenience kits contain BD ChloraPrep Clear – 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility assurance due to to wrinkles in the paper lidding which may breach the seal area. | 98 Kits |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2026-07-09 | Class II | Labeling Change Control | Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. | 45 kits |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2026-07-09 | Class II | Labeling Change Control | Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. | 63 kits |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2026-07-09 | Class II | Labeling Change Control | Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. | 78 kits |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2026-07-09 | Class II | Labeling Change Control | Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. | 78 kits |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2026-07-09 | Class II | Labeling Change Control | Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. | 120 Kits |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2026-07-09 | Class II | Labeling Change Control | Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. | 130 KITS |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2026-07-09 | Class II | Labeling Change Control | Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. | 78 kits |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2026-05-19 | Class II | Material/Component Contamination | The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin le | 11763 kits |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2026-05-19 | Class II | Material/Component Contamination | The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin le | 16223 kits |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2026-01-02 | Class II | Equipment maintenance | Tyvek bag seal issue which may compromise sterility of the kit. | 1,500 units |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2025-11-14 | Class II | Nonconforming Material/Component | Potential for incomplete seal on header bag. | 42 units |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2025-11-14 | Class II | Nonconforming Material/Component | Potential for incomplete seal on header bag. | 240 units |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2025-11-14 | Class II | Nonconforming Material/Component | Potential for incomplete seal on header bag. | 90 units |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2025-11-11 | Class I | Nonconforming Material/Component | Devices are not suitable for organ transplant. | 132 units |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2025-11-11 | Class I | Nonconforming Material/Component | Devices are not suitable for organ transplant. | 52 units |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2025-11-11 | Class I | Nonconforming Material/Component | Devices are not suitable for organ transplant. | 380 units |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2025-08-04 | Class II | Nonconforming Material/Component | Potential for open header bag seals, compromising sterility. | 57 units |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2025-08-04 | Class II | Nonconforming Material/Component | Potential for open header bag seals, compromising sterility. | 228 units |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2025-06-11 | Class II | Under Investigation by firm | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 40 units |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2025-06-11 | Class II | Under Investigation by firm | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 21 units |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2025-06-11 | Class II | Under Investigation by firm | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 626 units |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2025-06-11 | Class II | Under Investigation by firm | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 166 units |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2025-06-11 | Class II | Under Investigation by firm | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 321 units |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2025-06-11 | Class II | Under Investigation by firm | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 574 units |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2025-06-11 | Class II | Under Investigation by firm | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 203 units |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2025-06-11 | Class II | Under Investigation by firm | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 816 units |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2025-06-11 | Class II | Under Investigation by firm | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 85 units |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2025-06-11 | Class II | Under Investigation by firm | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 30 units |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2025-06-11 | Class II | Under Investigation by firm | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 128 units |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2025-06-11 | Class II | Under Investigation by firm | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 656 units |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2025-06-11 | Class II | Under Investigation by firm | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 46 units |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2025-06-11 | Class II | Under Investigation by firm | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 52 units |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2025-06-11 | Class II | Under Investigation by firm | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 24 units |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2025-03-31 | Class II | Nonconforming Material/Component | An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use. | 72 units |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2024-09-20 | Class II | Process control | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign bod | 100 eaches |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2024-09-20 | Class II | Process control | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign bod | 1,434 eaches |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2024-09-20 | Class II | Process control | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign bod | 117 eaches |
Showing 40 of 73.
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.