E.M Adams Co., Inc.
Minor Surgery Procedure Tray
105manufacturers in China registered for this device type
181catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (28), Zhejiang (23), Shanghai (16). 20 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 37 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Mobility Source Medical Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 26 |
| Guangdong Shunde LQX Health Technology Inc. | Foshan | Guangdong | Contract manufacturer | 24 |
Showing 12 of 105. All 105 manufacturers in China registered for Tray, Surgical, Instrument
Record
| Listed by | E.M. Adams Co., Inc., United States |
|---|---|
| FDA product code | FSM |
| Device type | Tray, Surgical, Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Manufacturer |
| 510(k) | K812133 |
| Record published | 2021-05-21 |
| Record revised | 2021-03-01 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| 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 |
| Packaging | Case of 20, case of 100, box of 20, case of 35, case of 7, case of 30 |
| Distribution end date | 2021-02-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14-70901D-1 | 8″ x7″ x 1″ | In distribution |
| 114-60222-1 | 7.75″ X 6.5″ X 2.25″ | In distribution |
| 14-3342-1 | 5″ X 9″ POUCH/KELLY FORCEPS, CURVED | In distribution |
| 14-3382-1 | 5″ X 9″ POUCH/IRIS FORCEPS, SERRATED | In distribution |
| 14-3407-1 | 5″ X 9″ POUCH/CRILE HEMOSTAD STRAIGHT | In distribution |
| 114-31617-1 | 8.75″ X 7″ X 1.25″ | In distribution |
| 114-3639-1 | 8.75″ X 7″ X 1.25″ | In distribution |
| 14-3349-1 | 5″ X 9″ POUCH/LISTER BANDAGE SCISSORS | In distribution |
| 114-60785-1 | 7.75″ X 6.5″ X 2.25″ | In distribution |
| 14-3497-1 | 5″ X 9″ POUCH/ALLIGATOR FORCEPS | In distribution |
| 14-3335-1 | 5″ X 9″ POUCH/IRIS SCISSORS, STRAIGHT | In distribution |
| 114-A2032-1 | 6″ X 12″ INSTRUMENT PACK | In distribution |
| 114-A11341-1 | 8.75″ X 7″ X 1.5″ | In distribution |
| 14-50206-1 | 8.75″ X 7″ X 1.5″ | In distribution |
| 14-B373-1 | 6″ X 10″ PACK | In distribution |
| 14-3591-1 | 5″ X 9″ POUCH/MAYO SCISSORS, CURVED | In distribution |
| 114-B3208-1 | 8.25″ x 5.25″ x.875″ | In distribution |
| 114-B3220-1 | 8.25″ x 5.25″ x.875″ | In distribution |
| 14-50103-1 | 7.75″ X 6.5″ X2.25″ | In distribution |
| 114-E209-1 | 9.75″ x 4″ x 2″ | In distribution |
| 14-3345-1 | 5″ X9″ POUCH/ROCHESTER PEAN, STRAIGHT | In distribution |
| 114-A856-1 | 11″ X 9.5″ X3″ | In distribution |
| 114-A11307-1 | 8″ X 12″ SPECULUM PACK | In distribution |
| 14-3392-1 | 5″ X 9″ POUCH/TUBE OCCLUDING FORCEPS | In distribution |
| 114-3869-1 | 8.75″ X 7″ X 1.25″ | In distribution |
| 14-3444-1 | 5″ X 9″ POUCH/PAPER TAPE MEASURE | In distribution |
| 14-3393-1 | 5″ X 9″ POUCH/PLASTIC TUBING CLAMP | In distribution |
| 114-31401-1 | 8.75″ X 7″ X 1.25″ | In distribution |
| 114-A11105-1 | 6″ X 10″ INSTRUMENT PACK | In distribution |
| 14-A673-1 | 10.25″ X 9.5″ X 2.75″ | In distribution |
| 14-A1200-1 | 6″ x 10″ PACK | In distribution |
| 114-61184-1 | 7.75″ X 6.5″ X 2.25″ | In distribution |
| 14-3916-1 | 8.75″ X 7″ X 1.5″ | In distribution |
| 14-3336-1 | 5″ X 9″ POUCH/THUMB FORCEPS,SERRATED | In distribution |
| 114-61058-1 | 7.75″ X 6.5″ X 2.25″ | In distribution |
| 14-3340-1 | 5″ X 9″ POUCH/WEBSTER NEEDLE HOLDER | In distribution |
| 14-3346-1 | 5″ X 9″ POUCH/MAYO HEAGER NEEDLE HOLDER | In distribution |
| 114-3918-1 | 8.75″ X 7″ X 1.25″ | In distribution |
| 114-B321-1 | 8.25″ x 5.25″ x.875″ | In distribution |
| 114-5636-1 | 6″ X 3.75″ X 5″ | In distribution |
| 14-60703-1 | 8″ x 7″ x 1″ | In distribution |
| 114-31613-1 | 8.75″ x 7″ x 1.5″ | In distribution |
| 14-3358-1 | 5″ X 9″ POUCH/FOERSTER SPONGE FORCEPS | In distribution |
| 114-31125-1 | 8.75″ X 7″ X 1.25″ | In distribution |
| 14-3450-1 | 5″ X 9″ POUCH/BAYONET FORCEPS | In distribution |
| 14-117-1 | 8″ x 12″ BAG | In distribution |
| 14-70502-1 | 8″ x 7″ x 1″ | In distribution |
| 114-31121-1 | 8.75″ X 7″ X 1.25″ | In distribution |
| 14-3348-1 | 5″ X 9″ POUCH/GREEN PLASTIC TUBING CLAMP | In distribution |
| 14-3328-1 | 8″ X 12″ BAG/ROCHESTER PEAN FORCEPS, CURVED | In distribution |
| 14-118-1 | 8″ x 12″ BAG | In distribution |
| 14-3373-1 | 5″ X 9″ POUCH/IRIS SPLINTER FORCEPS 1 X 2 | In distribution |
| 114-B721-1 | 8.25″ x 5.25″ x.875″ | In distribution |
| 114-4095-1 | 8″ X7″ X 1″ | In distribution |
| 14-3497-1 | 5″ X 9″ POUCH/ALLIGATOR FORCEPS | In distribution |
| 14-3369-1 | 5″ X 9″ POUCH/WIRE CUTTER SCISSORS, STRAIGHT | In distribution |
| 14-3334-1 | 5″ X 9″ POUCH/IRIS SCISSORS, CURVED | In distribution |
| 14-70903-1 | 8″ x7″ x 1″ | In distribution |
| 14-3363-1 | 5″ X 9″ POUCH/FIELCHENFELD SPLINTER FORCEPS | In distribution |
| 14-3333-1 | 5″ X 9″ POUCH/SHARP SHARP SCISSORS, STRAIGHT | In distribution |
| 14-3356-1 | 5″ X 9″ POUCH/ROCHESTER PEAN, CURVED | In distribution |
| 14-3882-1 | 8.75″ X 7″ X 1.5″ | In distribution |
| 14-3344-1 | 5″ X 9″ POUCH/MOSQUITO FORCEPS, CURVED | In distribution |
| 114-A519-1 | 5″ X 9″ INSTRUMENT PACK | In distribution |
| 14-3343-1 | 5″ X 9″ POUCH/MOSQUITO FORCEPS, STRAIGHT | In distribution |
| 14-3341-1 | 5″ X 9″ POUCH/KELLY FORCEPS, STRAIGHT | In distribution |
| 114-61181-1 | 7.75″ X 6.5″ X 2.25″ | In distribution |
| 114-B3009-1 | 10″ X 8″ X 6.25″ | In distribution |
| 114-A11329-1 | 6″ X 10″ INSTRUMENT PACK | In distribution |
| 14-50106-1 | 7.75″ X 6.5″ X2.25″ | In distribution |
| 14-70902D-1 | 8″ x7″ x 1″ | In distribution |
| 14-3886-1 | 8.75″ X 7″ X 1.5″ | In distribution |
| 114-A11361-1 | 8″ X 12″ INSTRUMENT PACK | In distribution |
| 14-3915-1 | 8.75″ X 7″ X 1.5″ | In distribution |
| 114-31487-1 | 8.75″ X 7″ X 1.25″ | In distribution |
| 14-70902-1 | 8″ x7″ x 1″ | In distribution |
| 14-3338-1 | 5″ X 9″ POUCH/ADSON FORCEPS, 1 X 2 | In distribution |
| 114-A3609-1 | 8.75″ X 7″ X 1.25″ | In distribution |
| 14-3337-1 | 5″ X 9″ POUCH/ADSON FORCEPS, SERRATED | In distribution |
| 14-3350-1 | 5″ X 9″ POUCH/PLASTIC FORESTER SPONGE FORCEPS | In distribution |
| 114-A3608-1 | 8.75″ X 7″ X 1.25″ | In distribution |
| 14-3332-1 | 5″ X 9″ POUCH/SHARP BLUNT SCISSORS, STRAIGHT | In distribution |
| 114-A2031-1 | 6″ X 12″ INSTRUMENT PACK | In distribution |
| 114-A1228-1 | 6″ X 12″ INSTRUMENT PACK | In distribution |
| 14-50203-1 | 8.75″ X 7″ X 1.5″ | In distribution |
| 14-3370-1 | 5″ X 9″ POUCH/WIRE CUTTER SCISSORS, ANGLED | In distribution |
| 114-A6089-1 | 10.25″ X 9.5″ X 2.75″ | In distribution |
| 14-3339-1 | 5″ X 9″ POUCH/DERF NEEDLE HOLDER | In distribution |
| 114-31064-1 | 9.5″ X 5.5 X.75 | In distribution |
| 14-3881-1 | 8.75″ X 7″ X 1.5″ | In distribution |
| 14-3350-1 | 5″ X 9″ POUCH/PLASTIC FORESTER SPONGE FORCEPS | Withdrawn |
| 14-3346-1 | 5″ X 9″ POUCH/MAYO HEAGER NEEDLE HOLDER | Withdrawn |
| 114-31064-1 | 9.5″ X 5.5 X.75 | Withdrawn |
| 14-3343-1 | 5″ X 9″ POUCH/MOSQUITO FORCEPS, STRAIGHT | Withdrawn |
| 14-A1200-1 | 6″ x 10″ PACK | Withdrawn |
| 114-B721-1 | 8.25″ x 5.25″ x.875″ | Withdrawn |
| 14-70902-1 | 8″ x7″ x 1″ | Withdrawn |
| 114-3639-1 | 8.75″ X 7″ X 1.25″ | Withdrawn |
| 14-3591-1 | 5″ X 9″ POUCH/MAYO SCISSORS, CURVED | Withdrawn |
| 114-B3220-1 | 8.25″ x 5.25″ x.875″ | Withdrawn |
| 14-B373-1 | 6″ X 10″ PACK | Withdrawn |
| 114-A6089-1 | 10.25″ X 9.5″ X 2.75″ | Withdrawn |
| 14-3358-1 | 5″ X 9″ POUCH/FOERSTER SPONGE FORCEPS | Withdrawn |
| 14-3450-1 | 5″ X 9″ POUCH/BAYONET FORCEPS | Withdrawn |
| 14-3349-1 | 5″ X 9″ POUCH/LISTER BANDAGE SCISSORS | Withdrawn |
| 114-5636-1 | 6″ X 3.75″ X 5″ | Withdrawn |
| 14-3916-1 | 8.75″ X 7″ X 1.5″ | Withdrawn |
| 14-3392-1 | 5″ X 9″ POUCH/TUBE OCCLUDING FORCEPS | Withdrawn |
| 114-31617-1 | 8.75″ X 7″ X 1.25″ | Withdrawn |
| 14-3341-1 | 5″ X 9″ POUCH/KELLY FORCEPS, STRAIGHT | Withdrawn |
| 14-3339-1 | 5″ X 9″ POUCH/DERF NEEDLE HOLDER | Withdrawn |
| 14-A673-1 | 10.25″ X 9.5″ X 2.75″ | Withdrawn |
| 114-A11329-1 | 6″ X 10″ INSTRUMENT PACK | Withdrawn |
| 14-3334-1 | 5″ X 9″ POUCH/IRIS SCISSORS, CURVED | Withdrawn |
| 114-31653-1 | 8.75″ X 7″ X 1.25″ | Withdrawn |
| 114-31401-1 | 8.75″ X 7″ X 1.25″ | Withdrawn |
| 114-A11105-1 | 6″ X 10″ INSTRUMENT PACK | Withdrawn |
| 114-3918-1 | 8.75″ X 7″ X 1.25″ | Withdrawn |
| 14-3882-1 | 8.75″ X 7″ X 1.5″ | Withdrawn |
| 14-3370-1 | 5″ X 9″ POUCH/WIRE CUTTER SCISSORS, ANGLED | Withdrawn |
| 14-3915-1 | 8.75″ X 7″ X 1.5″ | Withdrawn |
| 14-60703-1 | 8″ x 7″ x 1″ | Withdrawn |
| 14-3336-1 | 5″ X 9″ POUCH/THUMB FORCEPS,SERRATED | Withdrawn |
| 114-A519-1 | 5″ X 9″ INSTRUMENT PACK | Withdrawn |
| 114-A11361-1 | 8″ X 12″ INSTRUMENT PACK | Withdrawn |
| 114-A2032-1 | 6″ X 12″ INSTRUMENT PACK | Withdrawn |
| 114-60785-1 | 7.75″ X 6.5″ X 2.25″ | Withdrawn |
| 14-3886-1 | 8.75″ X 7″ X 1.5″ | Withdrawn |
| 14-3588-1 | 5″ X 9″ POUCH/MARK NEEDLE #18 | Withdrawn |
| 114-31125-1 | 8.75″ X 7″ X 1.25″ | Withdrawn |
| 14-3348-1 | 5″ X 9″ POUCH/GREEN PLASTIC TUBING CLAMP | Withdrawn |
| 14-3356-1 | 5″ X 9″ POUCH/ROCHESTER PEAN, CURVED | Withdrawn |
| 114-A11307-1 | 8″ X 12″ SPECULUM PACK | Withdrawn |
| 14-50203-1 | 8.75″ X 7″ X 1.5″ | Withdrawn |
| 114-E209-1 | 9.75″ x 4″ x 2″ | Withdrawn |
| 114-A2031-1 | 6″ X 12″ INSTRUMENT PACK | Withdrawn |
| 114-31752-1 | 8.75″ X 7″ X 1.25″ | Withdrawn |
| 114-60222-1 | 7.75″ X 6.5″ X 2.25″ | Withdrawn |
| 14-118-1 | 8″ x 12″ BAG | Withdrawn |
| 114-A3608-1 | 8.75″ X 7″ X 1.25″ | Withdrawn |
| 14-3345-1 | 5″ X9″ POUCH/ROCHESTER PEAN, STRAIGHT | Withdrawn |
| 14-3444-1 | 5″ X 9″ POUCH/PAPER TAPE MEASURE | Withdrawn |
| 114-3869-1 | 8.75″ X 7″ X 1.25″ | Withdrawn |
| 14-3335-1 | 5″ X 9″ POUCH/IRIS SCISSORS, STRAIGHT | Withdrawn |
| 14-70902D-1 | 8″ x7″ x 1″ | Withdrawn |
| 14-50103-1 | 7.75″ X 6.5″ X2.25″ | Withdrawn |
| 114-31487-1 | 8.75″ X 7″ X 1.25″ | Withdrawn |
| 14-3363-1 | 5″ X 9″ POUCH/FIELCHENFELD SPLINTER FORCEPS | Withdrawn |
| 114-A11341-1 | 6″ X 10″ INSTRUMENT PACK | Withdrawn |
| 114-B321-1 | 8.25″ x 5.25″ x.875″ | Withdrawn |
| 14-3497-1 | 5″ X 9″ POUCH/ALLIGATOR FORCEPS | Withdrawn |
| 114-A856-1 | 11″ X 9.5″ X3″ | Withdrawn |
| 14-3373-1 | 5″ X 9″ POUCH/IRIS SPLINTER FORCEPS 1 X 2 | Withdrawn |
| 14-50206-1 | 8.75″ X 7″ X 1.5″ | Withdrawn |
| 14-3342-1 | 5″ X 9″ POUCH/KELLY FORCEPS, CURVED | Withdrawn |
| 114-31121-1 | 8.75″ X 7″ X 1.25″ | Withdrawn |
| 14-3369-1 | 5″ X 9″ POUCH/WIRE CUTTER SCISSORS, STRAIGHT | Withdrawn |
| 14-70502-1 | 8″ x 7″ x 1″ | Withdrawn |
| 14-3338-1 | 5″ X 9″ POUCH/ADSON FORCEPS, 1 X 2 | Withdrawn |
| 14-3382-1 | 5″ X 9″ POUCH/IRIS FORCEPS, SERRATED | Withdrawn |
| 114-61181-1 | 7.75″ X 6.5″ X 2.25″ | Withdrawn |
| 14-117-1 | 8″ x 12″ BAG | Withdrawn |
| 114-B3208-1 | 8.25″ x 5.25″ x.875″ | Withdrawn |
| 14-3393-1 | 5″ X 9″ POUCH/PLASTIC TUBING CLAMP | Withdrawn |
| 14-3333-1 | 5″ X 9″ POUCH/SHARP SHARP SCISSORS, STRAIGHT | Withdrawn |
| 14-50106-1 | 7.75″ X 6.5″ X2.25″ | Withdrawn |
| 114-B3009-1 | 10″ X 8″ X 6.25″ | Withdrawn |
| 114-61058-1 | 7.75″ X 6.5″ X 2.25″ | Withdrawn |
| 114-4095-1 | 8″ X7″ X 1″ | Withdrawn |
| 14-3407-1 | 5″ X 9″ POUCH/CRILE HEMOSTAD STRAIGHT | Withdrawn |
| 114-A1228-1 | 6″ X 12″ INSTRUMENT PACK | Withdrawn |
| 14-3340-1 | 5″ X 9″ POUCH/WEBSTER NEEDLE HOLDER | Withdrawn |
| 14-3344-1 | 5″ X 9″ POUCH/MOSQUITO FORCEPS, CURVED | Withdrawn |
| 14-70901D-1 | 8″ x7″ x 1″ | Withdrawn |
| 114-61184-1 | 7.75″ X 6.5″ X 2.25″ | Withdrawn |
| 14-3587-1 | 5″ X 9″ POUCH/MARK NEEDLE #19 | Withdrawn |
| 14-3332-1 | 5″ X 9″ POUCH/SHARP BLUNT SCISSORS, STRAIGHT | Withdrawn |
| 14-3337-1 | 5″ X 9″ POUCH/ADSON FORCEPS, SERRATED | Withdrawn |
| 14-70903-1 | 8″ x7″ x 1″ | Withdrawn |
| 14-3881-1 | 8.75″ X 7″ X 1.5″ | Withdrawn |
| 14-3328-1 | 8″ X 12″ BAG/ROCHESTER PEAN FORCEPS, CURVED | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| IMS | HU-Friedy MFG Co., LLC | 2,710 |
| Tray, Surgical, Instrument | Synthes Gmbh | 1,052 |
| Tray, Surgical, Instrument | Medtronic Sofamor Danek, Inc. | 1,012 |
| Hu-Friedy MFG Co., LLC. | HU-Friedy MFG Co., LLC | 666 |
| Aptus | Medartis Inc. | 588 |
| Acumed | Acumed LLC | 566 |
| Aesculap | Aesculap AG | 532 |
| Sklar | Sklar Corporation | 465 |
| Hu-Friedy | HU-Friedy MFG Co., LLC | 438 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 429 |
| Level ONE | KLS-Martin L.P. | 341 |
| Bahadir USA | Bahadir USA LLC | 300 |
Showing 12 of 3,212. All products under Tray, Surgical, Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K843723 | 1984-10-23 |
| K812134 | 1982-01-15 |
| K812133 | 1982-01-08 |
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.