ClearanceBrief
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

CodeDeviceRecords
EAJApron, Leaded24
IWOApron, Protective13

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Apr 2, 2026Burlington Medical, LLC
Burlington Medical, Kilt Blockers.
Open, Classified
IWONone listed
Apr 2, 2026Burlington Medical, LLC
Burlington Medical, Blockers.
Open, Classified
IWONone listed
Apr 2, 2026Burlington Medical, LLC
Burlington Medical, Demi Half Aprons.
Open, Classified
IWONone listed
Apr 2, 2026Burlington Medical, LLC
Burlington Medical, Half Aprons.
Open, Classified
IWONone listed
Apr 2, 2026Burlington Medical, LLC
Burlington Medical, Leg Wraps.
Open, Classified
IWONone listed
Apr 2, 2026Burlington Medical, LLC
Burlington Medical, Caps.
Open, Classified
IWONone listed
Apr 2, 2026Burlington Medical, LLC
Burlington Medical, Protective Sleeves.
Open, Classified
IWONone listed
Apr 2, 2026Burlington Medical, LLC
Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.
Open, Classified
IWONone listed
Apr 2, 2026Burlington Medical, LLC
Burlington Medical, Wrap Aprons.
Open, Classified
IWONone listed
Apr 2, 2026Burlington Medical, LLC
Burlington Medical, Frontal Aprons
Open, Classified
IWONone listed
Apr 2, 2026Burlington Medical, LLC
Burlington Medical, Kilt
Open, Classified
IWONone listed
Apr 2, 2026Burlington Medical, LLC
Burlington Medical, Vest
Open, Classified
IWONone listed
Apr 2, 2026Burlington Medical, LLC
Burlington Medical, Thyroid Shield.
Open, Classified
IWONone listed
Jul 30, 2019Burlington 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
EAJNone listed
Jul 30, 2019Burlington 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
EAJNone listed
Jul 30, 2019Burlington 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
EAJNone listed
Jul 30, 2019Burlington 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
EAJNone listed
Jul 30, 2019Burlington 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
EAJNone listed
Jul 30, 2019Burlington 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
EAJNone listed
Jul 30, 2019Burlington 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
EAJNone listed
Jul 30, 2019Burlington 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
EAJNone listed
Jul 30, 2019Burlington 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
EAJNone listed
Jul 30, 2019Burlington 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
EAJNone listed
Jul 30, 2019Burlington 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
EAJNone listed
Jul 30, 2019Burlington 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
EAJNone listed
Jul 30, 2019Burlington 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
EAJNone listed
Jul 30, 2019Burlington 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
EAJNone listed
Jul 30, 2019Burlington 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
EAJNone listed
Jul 30, 2019Burlington Medical, LLC
Overlap Vest, Single Item, Product Number FVest, Part Numbers REFVEST*F, REFVEST*M, REFVESTE, REFVESTXLM, SEFVEST*F, SEFVEST*M
Terminated
EAJNone listed
Jul 30, 2019Burlington 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
EAJNone listed
Jul 30, 2019Burlington 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
EAJNone listed
Jul 30, 2019Burlington 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
EAJNone listed
Jul 30, 2019Burlington 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
EAJNone listed
Jul 30, 2019Burlington 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
EAJNone listed
Jul 30, 2019Burlington 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
EAJNone listed
Jul 30, 2019Burlington 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
EAJNone listed
Jul 30, 2019Burlington 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
EAJNone listed
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