15 results · 19ms · Sources: EU EUDAMED, US FDA

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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