Fvest
Custom FVEST: Full Overlap Front/Back Vest .35mm Regular Lead Size Three Extra Large Female, SLFVEST-3XF
6manufacturers in China registered for this device type
211catalogue numbers in this listing
24recalls on this code
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (2), Guangdong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Wellmed Dental Medical Supply Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 37 |
| Jiangsu Yongfa Medical Equipment Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 33 |
| Ekong Technology Co., Limited | Shenzhen | Guangdong | Manufacturer | 19 |
Record
| Listed by | Burlington Medical, LLC, United States |
|---|---|
| FDA product code | EAJ |
| Device type | Apron, Leaded |
| Device class | Class 1 |
| Regulation | 21 CFR 892.6500 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-10-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RPRFLOV-MF | In distribution | |
| RTLFLOV-XXSF | In distribution | |
| STLFLOV-MF | In distribution | |
| RBFVEST*F | Tailored | In distribution |
| SBFVEST-SF | In distribution | |
| RLFVEST8XLM | 8XL Male | In distribution |
| RTLFLOV-PF | In distribution | |
| SBFVEST-2XM | In distribution | |
| UBFVEST-PLUS | In distribution | |
| UBFVEST-3XM | In distribution | |
| RBFVESTXLM | Male XL | In distribution |
| UBFVEST-LM | In distribution | |
| SLFVEST*M | In distribution | |
| RPRFLOV-7XF | In distribution | |
| RPRFLOV-8XF | In distribution | |
| SBFVEST-2XF | In distribution | |
| RBFVEST8XLM | 8XL Male | In distribution |
| RTLFLOV-SF | In distribution | |
| STLFLV-XXM | In distribution | |
| RLFVEST4XLF | 4XL Female | In distribution |
| RBFVESTXSF | XS Female | In distribution |
| RCCFLOV-XXF | In distribution | |
| RLFVEST-PLUS | In distribution | |
| RPRFLOV-6XF | In distribution | |
| RPRFLOV-5XF | In distribution | |
| RTLFLOV-XXM | In distribution | |
| UBFVEST-SM | In distribution | |
| STLFLOV-XXSF | In distribution | |
| SLFVESTXSF | XS Female | In distribution |
| RCCFLOV-LM | In distribution | |
| RTLFLOV-7XF | In distribution | |
| RTLFLOV-5XF | In distribution | |
| RBFVEST-2XM | In distribution | |
| RLFVEST8XLF | 8XL Female | In distribution |
| RLFVEST5XLM | 5XL Male | In distribution |
| RTLFLOV-XXF | In distribution | |
| RPRFLOV-LF | In distribution | |
| STLFLOV-MM | In distribution | |
| RCCFLOV-5XM | In distribution | |
| RBFVEST-XXSF | In distribution | |
| RCCFLOV-6XM | In distribution | |
| RCCFLOV-3XM | In distribution | |
| RBFVEST-LF | In distribution | |
| RBFVEST5XLF | 5XL Female | In distribution |
| RTLFLOV-SM | In distribution | |
| RLFVEST-MF | In distribution | |
| RLFVEST-LF | In distribution | |
| STLFLOV-XSF | In distribution | |
| STLFLOV-8XF | In distribution | |
| UBFVEST-MM | In distribution | |
| RLFVEST7XLM | 7XL Male | In distribution |
| RTLFLOV-3XM | In distribution | |
| SLFVEST-MM | In distribution | |
| SLFVEST-LM | In distribution | |
| UBFVEST-XSM | In distribution | |
| STLFLOV-SF | In distribution | |
| STLFLOV-4XM | In distribution | |
| RBFVEST*M | In distribution | |
| RTLFLOV-7XM | In distribution | |
| SCCFLOV-XLM | In distribution | |
| RPRFLOV-4XF | In distribution | |
| SLFVEST-MF | In distribution | |
| RLFVEST-LM | In distribution | |
| STLFLOV-XLF | In distribution | |
| RTLFLOV-MM | In distribution | |
| STLFLOV-LM | In distribution | |
| RBFVEST-MF | In distribution | |
| RBFVEST8XLF | 8XL Female | In distribution |
| SLFVEST-2XF | In distribution | |
| RTLFLOV-MF | In distribution | |
| RBFVEST-3XF | In distribution | |
| RBFVEST-LM | In distribution | |
| RLFVEST-XLM | In distribution | |
| RTLFLOV-8XM | In distribution | |
| UBFVEST-LF | In distribution | |
| SCCFLOV-XSM | In distribution | |
| SLFVEST*F | In distribution | |
| SLFVESTXSM | XS Male | In distribution |
| RLFVESTXSF | XS Female | In distribution |
| SBFVEST-XLM | In distribution | |
| STLFLOV-LF | In distribution | |
| SBFVESTXSF | XS Female | In distribution |
| SLFVEST-2XM | In distribution | |
| RCCFLOV-XXSF | In distribution | |
| SBFVESTXSM | XS Male | In distribution |
| STLFLOV-PF | In distribution | |
| RBFVEST-XLM | In distribution | |
| RTLFLOV-4XF | In distribution | |
| RBFVEST*M | Tailored | In distribution |
| RBFVEST-2XF | In distribution | |
| RLFVEST-SM | In distribution | |
| RLFVEST-SF | In distribution | |
| SBFVEST-PLUS | In distribution | |
| RBFVEST4XLM | 4XL Male | In distribution |
| STLFLOV-7XM | In distribution | |
| RLFVEST*F | Tailored | In distribution |
| SLFVEST-SM | In distribution | |
| RBFVEST*F | In distribution | |
| RCCFLOV-MM | In distribution | |
| RBFVESTC | Male Large | In distribution |
| SBFVEST-LM | In distribution | |
| RBFVESTXLF | Female XL | In distribution |
| SLFVEST-XXSF | In distribution | |
| RBFVESTA | Male Small | In distribution |
| STLFLOV-XXF | In distribution | |
| RCCFLOV-XSM | In distribution | |
| RLFVEST6XLM | 6XL Male | In distribution |
| SBFVEST-3XF | In distribution | |
| STLFLOV-3XF | In distribution | |
| RBFVEST6XLF | 6XL Female | In distribution |
| RLFVEST-XLF | In distribution | |
| RLFVEST*M | Tailored | In distribution |
| SLFVEST-PLUS | In distribution | |
| RBFVESTXSM | XS Male | In distribution |
| UBFVEST-XLM | In distribution | |
| RTLFLOV-8XF | In distribution | |
| RLFVESTA | Male Small | In distribution |
| RLFVEST-2XM | In distribution | |
| UBFVEST-XSF | In distribution | |
| STLFLOV-4XF | In distribution | |
| UBFVEST-2XF | In distribution | |
| RBFVEST3XLM | 3XL Male | In distribution |
| RBFVEST-3XM | In distribution | |
| RLFVEST*M | In distribution | |
| RPRFLOV-PF | In distribution | |
| RTLFLOV-6XM | In distribution | |
| SCCFLOV-XXM | In distribution | |
| UBFVEST-XLF | In distribution | |
| RCCFLOV-8XM | In distribution | |
| UBFVEST-3XF | In distribution | |
| RTLFLOV-6XF | In distribution | |
| RLFVEST7XLF | 7XL Female | In distribution |
| SLFVEST-3XF | In distribution | |
| SLFVEST-XLM | In distribution | |
| RBFVEST5XLM | 5XL Male | In distribution |
| SLFVEST-LF | In distribution | |
| RBFVEST-MM | In distribution | |
| RLFVEST-XXSF | In distribution | |
| SBFVEST-XLF | In distribution | |
| SBFVEST*F | In distribution | |
| RBFVESTF | Female Large | In distribution |
| RBFVEST6XLM | 6XL Male | In distribution |
| RLFVEST-2XF | In distribution | |
| SLFVEST-3XM | In distribution | |
| RTLFLOV-5XM | In distribution | |
| RBFVEST4XLF | 4XL Female | In distribution |
| RLFVEST3XLM | 3XL Male | In distribution |
| UBFVEST-2XM | In distribution | |
| UBFVEST-MF | In distribution | |
| RBFVESTXXLM | 2XL Male | In distribution |
| RBFVESTB | Male Medium | In distribution |
| RTLFLOV-3XF | In distribution | |
| RBFVESTD | Female Small | In distribution |
| RTLFLOV-XSF | In distribution | |
| UBFVEST-XXSF | In distribution | |
| RBFVESTXXLF | 2XL Female | In distribution |
| SBFVEST-SM | In distribution | |
| RTLFLOV-LF | In distribution | |
| RLFVEST-MM | In distribution | |
| RCCFLOV-XXM | In distribution | |
| UBFVEST-SF | In distribution | |
| RLFVESTXSM | XS Male | In distribution |
| STLFLOV-3XM | In distribution | |
| RBFVESTE | Female Medium | In distribution |
| RCCFLOV-7XM | In distribution | |
| STLFLOV-5XM | In distribution | |
| RLFVEST6XLF | 6XL Female | In distribution |
| RTLFLOV-4XM | In distribution | |
| SBFVEST-MF | In distribution | |
| STLFLOV-7XF | In distribution | |
| STLFLOV-8XM | In distribution | |
| UBFVEST*F | In distribution | |
| RPRFLOV-3XF | In distribution | |
| SBFVEST-XXSF | In distribution | |
| RLFVEST4XLM | 4XL Male | In distribution |
| RBFVEST7XLF | 7XL Female | In distribution |
| RCCFLOV-XLM | In distribution | |
| SBFVEST-3XM | In distribution | |
| SCCFLOV-SM | In distribution | |
| RCCFLOV-SF | In distribution | |
| STLFLOV-6XF | In distribution | |
| RLFVEST5XLF | 5XL Female | In distribution |
| SLFVEST-SF | In distribution | |
| RCCFLOV-SM | In distribution | |
| RBFVEST-SM | In distribution | |
| RLFVEST3XLF | 3XL Female | In distribution |
| RTLFLOV-XSM | In distribution | |
| RLFVEST-3XM | In distribution | |
| UBFVEST*M | In distribution | |
| RBFVEST7XLM | 7XL Male | In distribution |
| RCCFLOV-4XM | In distribution | |
| RBFVEST-XLF | In distribution | |
| SBFVEST-LF | In distribution | |
| RBFVEST-PLUS | In distribution | |
| RCCFLOV-XSF | In distribution | |
| RBFVESTG | Female Large Plus | In distribution |
| STLFLOV-6XM | In distribution | |
| RTLFLOV-XLM | In distribution | |
| SLFVEST-XLF | In distribution | |
| SBFVEST*M | In distribution | |
| RLFVEST-3XF | In distribution | |
| RCCFLOV-XLF | In distribution | |
| STLFLV-SM | In distribution | |
| SBFVEST-MM | In distribution | |
| STLFLOV-5XF | In distribution | |
| RTLFLOV-LM | In distribution | |
| RBFVEST-SF | In distribution | |
| RTLFLOV-XLF | In distribution | |
| RBFVEST3XLF | 3XL Female | In distribution |
| STLFLV-XSM | In distribution | |
| STLFLV-XLM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Thyroid Shield | Burlington Medical, LLC | 1,161 |
| Wolf X-Ray | Flow X-Ray Corp. | 909 |
| ComfortLite | Aadco Medical, Inc. | 538 |
| Palmero Healthcare, LLC | Palmero Healthcare LLC | 402 |
| Euro | Burlington Medical, LLC | 390 |
| Rayshield | Aadco Medical, Inc. | 380 |
| 601 | Burlington Medical, LLC | 352 |
| F17 | Burlington Medical, LLC | 345 |
| Techno-Aide | Techno-Aide, Inc. | 327 |
| F111 | Burlington Medical, LLC | 322 |
| Skirt | Burlington Medical, LLC | 312 |
| A10 | Burlington Medical, LLC | 286 |
Showing 12 of 118. All products under Apron, Leaded
Recalls
24 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 129 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 210 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 332 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 7 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 22 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 37 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 9 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 49 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 7 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 48 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 1 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 2190 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 6 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 51 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 807 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 2 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 2 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 3 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 310 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 104 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 39 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 23 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 23 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 9 | 2023-04-28 |
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.