15 results
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19ms
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Sources: EU EUDAMED, US FDA
LSC LIFESTAND COMPACT
FDA 510(k)
FDA Class 2
·Physical Medicine
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526189805·LEVAMED ACTIVE ANKLE SUP BLACK R V
ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION
FDA 510(k)
FDA Class 2
·Orthopedic
CADENCE PRECISION INJECTOR, MODEL 103-0304
FDA 510(k)
FDA Class 2
·Cardiovascular
2027971-2022-041535
FDA Adverse Event
Injury
·NOBEL BIOCARE USA, LLC·Product code DZE·February 15, 2022
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·April 8, 2013
LIGASURE IMPACT
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·March 10, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·May 8, 2008
BIOLOX HEAD HIP IMPLANT
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·April 25, 2019
UNKNOWN BIOLOX HEAD
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·February 13, 2018
CERASUL, HEAD, M/0, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·November 4, 2019
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013