Company
Burlington Medical, LLC
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
37recalls (13 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 2, 2026 | Burlington Medical, LLC Burlington Medical, Kilt Blockers. Open, Classified |
IWO | None listed |
| Apr 2, 2026 | Burlington Medical, LLC Burlington Medical, Blockers. Open, Classified |
IWO | None listed |
| Apr 2, 2026 | Burlington Medical, LLC Burlington Medical, Demi Half Aprons. Open, Classified |
IWO | None listed |
| Apr 2, 2026 | Burlington Medical, LLC Burlington Medical, Half Aprons. Open, Classified |
IWO | None listed |
| Apr 2, 2026 | Burlington Medical, LLC Burlington Medical, Leg Wraps. Open, Classified |
IWO | None listed |
| Apr 2, 2026 | Burlington Medical, LLC Burlington Medical, Caps. Open, Classified |
IWO | None listed |
| Apr 2, 2026 | Burlington Medical, LLC Burlington Medical, Protective Sleeves. Open, Classified |
IWO | None listed |
| Apr 2, 2026 | Burlington Medical, LLC Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage. Open, Classified |
IWO | None listed |
| Apr 2, 2026 | Burlington Medical, LLC Burlington Medical, Wrap Aprons. Open, Classified |
IWO | None listed |
| Apr 2, 2026 | Burlington Medical, LLC Burlington Medical, Frontal Aprons Open, Classified |
IWO | None listed |
| Apr 2, 2026 | Burlington Medical, LLC Burlington Medical, Kilt Open, Classified |
IWO | None listed |
| Apr 2, 2026 | Burlington Medical, LLC Burlington Medical, Vest Open, Classified |
IWO | None listed |
| Apr 2, 2026 | Burlington Medical, LLC Burlington Medical, Thyroid Shield. Open, Classified |
IWO | None listed |
| 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 |