15 results · 22ms · Sources: EU EUDAMED, US FDA

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IMPAX VOLUME VIEWING

FDA 510(k)
FDA Class 2 ·Radiology

Ambler Surgical

FDA UDI
AMBLER SURGICAL CORP.·10190660198418·Atkinson retrobulbar anesthesia needle, 23 gaug...

SURGISTAR

FDA UDI
SURGISTAR, INC.·00878799006585·

DONJOY

FDA UDI
DJO, LLC·00888912157766·ICEMAN CLEARCUBE W/ANKLE WRAP-ON PAD, NS, RH

MicroSelectron Digital

FDA UDI
Nucletron B.V.·08717213026414·microSelectron Transfer Tube for 6F Flexibles (28)

ANTI-B(MURINE MONOCLONAL) SERIES 3

FDA Adverse Event
Malfunction ·IMMUCOR, INC.·Product code KSZ·April 8, 2008

DONJOY

FDA UDI
DJO, LLC·00190446738398·ICEMAN CLEAR3 W/ ANKLE WRAP-ON PAD, NS, RH, ORT...

ANTI-A (MURINE MONOCLONAL) SERIES 1

FDA Adverse Event
Malfunction ·IMMUCOR, INC.·Product code KSZ·April 8, 2008

WILDCAT CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

THE PICC WAND (R) PEELABLE SAFETY INTRODUCER

FDA 510(k)
FDA Class 2 ·Cardiovascular

PLM A+ SPANISH DEVICE

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 7, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 2, 2011

EXTERNAL NEUROSTIMULATOR

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code LGW·August 13, 2008

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Model Number L231, PROPONENT DR EL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025