37 results
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33ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LEW MDI O-BALL COLLARED IMPLANT,
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772813872·GENUMEDI PRO SILVER SIZE VII
Cervical Interbody 17mm x 13.5mm x 7mm Packaging
FDA UDI
XENCO MEDICAL LLC·B064XM11217071·Cervical Interbody 17mm x 13.5mm x 7mm
CancelleX™ 17mm x 13.5mm x 7mm Cervical Interbody
FDA UDI
XENCO MEDICAL LLC·B064XM3D31217071·
SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER, SINGLE STEP HOLDERS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FULACCESS MODEL 1.0
FDA 510(k)
FDA Class 2
·Radiology
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 3, 2026
MARATHON MICRO CATHETER
FDA Adverse Event
Injury
·EV3 NEUROVASCULAR·Product code DYG·May 21, 2013
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·September 26, 2014
HUTIV FINAL ASSY, REV, RIGHT
FDA Adverse Event
Malfunction
·LIEBEL-FLARSHEIM CO.·Product code KQS·May 19, 2011
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·May 20, 2026
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·October 7, 2025
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 24, 2026