16 results
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38ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FLEXI SEAL SIGNAL (FMS)
FDA Adverse Event
Injury
·CONVATEC INC.·Product code KNT·October 11, 2016
Truline
FDA UDI
Arbill Industries, Inc.·10850052602014·
Truline
FDA UDI
Arbill Industries, Inc.·00850052602253·Made in Malaysia. Blue disposable nitrile. Size...
CoRoent
FDA UDI
Nuvasive, Inc.·00887517636102·CoRoent Ant TLIF PEEK, 11x12x34mm 12°
PINNACLE®
FDA UDI
B. BRAUN MEDICAL INC.·04046964200311·PINNACLE® 9-Lead Vented Transfer Set
AMS SOFT-TISSUE APPROXIMATION SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT
FDA 510(k)
FDA Class 1
·Microbiology
AQUILEX FLUID CONTROL SYSTEM
FDA Adverse Event
Malfunction
·W.O.M. WORLD OF MEDICINE GMBH·Product code HIG·March 12, 2020
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 14, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 23, 2014
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·May 27, 2011
CARDIOSAVE HYBRID
FDA Adverse Event
Injury
·DATASCOPE CORP. - MAHWAH·Product code DSP·June 11, 2020
CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·January 16, 2013
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 L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025