Apron, Leaded
Regulation 892.6500
0510(k)s in 12 months (6 all time)
0recalls in 12 months (25 all time)
0recalls that name a 510(k)
Top companies in EAJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Burlington Medical, LLC | 0 | 24 |
| E.M. Adams | 2 | 0 |
| Bt Medical Co., Inc. | 1 | 0 |
| Contour Fabricators Inc | 0 | 1 |
| Orthopedic Systems, Inc. | 1 | 0 |
| Rinn Dental Products | 1 | 0 |
| X-Tech, Ltd. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 30, 2019 | Burlington Medical, LLC Thyroid Collar Oversize, Product Number TS3, Part Numbers RBTS3-R, RETS3-R, RLTS3-R, RLTS3-SEP, RLTS3-T2T
Product Usage:
Products are designed to protect healthcare workers against scatter (secondary Terminated |
EAJ | None listed |
| Jul 30, 2019 | Burlington Medical, LLC Porta Shield, Product Number Porta Shield, Part Numbers PTS2, PTS3, PTS4
Product Usage:
Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluo Terminated |
EAJ | None listed |
| Jul 30, 2019 | Burlington Medical, LLC Hood, Product Number Hood, Part Numbers HOOD1, HOOD2
Product Usage:
Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiogr Terminated |
EAJ | None listed |
| Jul 30, 2019 | Burlington Medical, LLC Cap, Product Number Cap, Part Numbers CAP1, CAP2
Product Usage:
Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographi Terminated |
EAJ | None listed |
| Jul 30, 2019 | Burlington Medical, LLC Half Apron, Product Number Half Apron, Part Numbers REHALF*, REHALF3
Product Usage:
Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluorosc Terminated |
EAJ | None listed |
| Jul 30, 2019 | Burlington Medical, LLC Front/Back Apron with Stretch Velcro Closure, Product Number EURO, Part Numbers ECSEEUROA, ECSEEUROB, ECSEEUROC, ECSEEUROXLM, REEURO*F, REEURO*M, REEUROC, REEUROE, SEEURO*F, SEEURO*M, UEEURO*F
Produc Terminated |
EAJ | None listed |
| Jul 30, 2019 | Burlington Medical, LLC Frontal Apron with Quick Drop Velcro Closure (no elastic), Product Number 401, Part Numbers RE401*M
Product Usage:
Products are designed to protect healthcare workers against scatter (secondary) radi Terminated |
EAJ | None listed |
| Jul 30, 2019 | Burlington Medical, LLC Sleeve, Product Number Sleeve, Part Numbers RESL, SL 3 L, SL 3 M, SL 3 S, L 3 X, SL 3 XS, UESL
Product Usage:
Products are designed to protect healthcare workers against scatter (secondary) radiation Terminated |
EAJ | None listed |
| Jul 30, 2019 | Burlington Medical, LLC Thyroid Collar, Buckle Closure, Product Number TS4, Part Numbers RBTS4-R, RBTS4-T2T, RETS4-R, RLTS4-R, RLTS4-SEP, RLTS4-T2T, SBTS4-R, SETS4-T2T, SLTS4-R, UETS4-R
Product Usage:
Products are designed Terminated |
EAJ | None listed |
| Jul 30, 2019 | Burlington Medical, LLC Thyroid Collar, Velcro Closure, Product Number TS2, Part Numbers RBTS2-R, RETS2-R, RLTS2PED, RLTS2-R, RLTS2-SEP, RLTS2-T2T, SBTS2-R, SETS2-R, SLTS2-R, UETS2-R, UETS2-SEP, ULTS2-R, ULTS2-SEP
Product U Terminated |
EAJ | None listed |
| Jul 30, 2019 | Burlington Medical, LLC 1 pc Full Wrap Back Relief Apron, Product Number B52 Front & Back Apron, Part Numbers SEB52*F, UEB52*M
Product Usage:
Products are designed to protect healthcare workers against scatter (secondary) r Terminated |
EAJ | None listed |
| Jul 30, 2019 | Burlington Medical, LLC Thyroid Collar, Magnetic Closure, Product Number TS5, Part Numbers RBTS5-R, RBTS5-T2T, RLTS5-R, RLTS5-T2T, SLTS5-R
Product Usage:
Products are designed to protect healthcare workers against scatter ( Terminated |
EAJ | None listed |
| Jul 30, 2019 | Burlington Medical, LLC Kilt, Single Item, Product Number Kilt, Part Numbers ECREKILTF, ECREKILTXLF, REKILTA, REKILTB, REKILTXLF, REKILTXLM, REKILT*M, SEKILTB, SEKILTC, SEKILT*F, SEKILT*M
Product Usage:
Products are designe Terminated |
EAJ | None listed |
| Jul 30, 2019 | Burlington Medical, LLC Peak Vest, Single Item, Product Number PVest, Part Numbers REPVEST*M, SEPVESTE, SEPVEST*F
Product Usage:
Products are designed to protect healthcare workers against scatter (secondary) radiation whil Terminated |
EAJ | None listed |
| Jul 30, 2019 | Burlington Medical, LLC 2 pc Full Wrap Vest & Kilt Back-Saver , Product Number PVK, Part Numbers REPVK*F, REPVK*M, REPVKE, REPVKF, REPVKXLM, SEPVK*F, SEPVK*M, SEPVKE, UEPVK*F
Product Usage:
Products are designed to protect Terminated |
EAJ | None listed |
| Jul 30, 2019 | Burlington Medical, LLC Overlap Vest, Single Item, Product Number FVest, Part Numbers REFVEST*F, REFVEST*M, REFVESTE, REFVESTXLM, SEFVEST*F, SEFVEST*M Terminated |
EAJ | None listed |
| Jul 30, 2019 | Burlington Medical, LLC 2 pc Full Overlap Vest & Kilt, Single Item, Product Number FVK, Part Numbers REFVK*F, REFVK*M, REFVKB, REFVKD, REFVKE, REFVKF, SEFVK*F, SEFVK*M, SEFVKE, SEFVKXLM
Product Usage:
Products are designed Terminated |
EAJ | None listed |
| Jul 30, 2019 | Burlington Medical, LLC Vest, Single Item, Product Number Vest, Part Numbers ECREVESTD, ECREVESTF, ECREVESTXLF, REVEST*M, REVESTB, REVESTC, SEVEST*F, SEVEST*M, SEVESTA, SEVESTB, SEVESTC, UEVESTB, UEVESTXLM
Product Usage:
Pr Terminated |
EAJ | None listed |
| Jul 30, 2019 | Burlington Medical, LLC 2 pc Full Wrap Vest & Kilt, Product Number VK, Part Numbers ECREVKA, ECREVKB, ECREVKC, ECREVKXLM, ECSEVKA, ECSEVKB, ECSEVKC, ECSEVKXLM, REVK*F, REVK*M, REVKB, REVKC, REVKE, REVKXXLM, SEVK*F, SEVK*M, S Terminated |
EAJ | None listed |
| Jul 30, 2019 | Burlington Medical, LLC 1 pc Full Wrap Support Belt Apron, Product Number F111, Part Numbers MTREF111*F, MTREF111E, MTREF111F, REF111*F, REF111*M, REF111B, REF111E, REF111F, SEF111*F, SEF111*M, SEF111C, SEF111D, SEF111E, SEF Terminated |
EAJ | None listed |
| Jul 30, 2019 | Burlington Medical, LLC Frontal Quick Drop OR Apron, Product Number 601, Part Numbers ECRE601A, ECRE601B, ECRE601C, ECRE601XLM, RE601*M, RE601C, RE601D, RE601XXLM
Product Usage:
Products are designed to protect healthcare w Terminated |
EAJ | None listed |
| Jul 30, 2019 | Burlington Medical, LLC Frontal Support Belt Apron, Product Number F-15, Part Numbers REF15*F, REF15*M, REF15B, REF15XLM
Product Usage:
Products are designed to protect healthcare workers against scatter (secondary) radiati Terminated |
EAJ | None listed |
| Jul 30, 2019 | Burlington Medical, LLC Frontal Apron Velcro Closure, Product Number F-17, Part Numbers REF17A, REF17B, REF17C, REF17D, REF17*F, REF17*M, REF17XLF, REF17XLM, REF17XXLM, REF173XLM, UEF17A, UEF17M, UEF17*F, UEF17*M, UEF17XLF, Terminated |
EAJ | None listed |
| Jul 30, 2019 | Burlington Medical, LLC Frontal Stretch Buckle Closure Apron, Product Number A-10, Part Numbers REA10A, REA10B, REA10C, REA10*F, REA10*M, UEA10*M
Product Usage:
Products are designed to protect healthcare workers against sc Terminated |
EAJ | None listed |
| Oct 13, 2016 | Contour Fabricators Inc Zero-Gravity Radiation Protection System
Radiology
Personnel protective shield. Terminated |
EAJ | None listed |
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