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