13 results · 21ms · Sources: EU EUDAMED, US FDA

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LGN PS HIGH FLEX XLPE SZ 1-2 13MM

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code JWH·August 9, 2017

LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL COMPONENTS

FDA 510(k)
FDA Class 2 ·Orthopedic

LGN PS HIGH FLEX XLPE SZ 1-2 13MM

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code JWH·August 9, 2017

n/a

FDA UDI
HANS RUDOLPH, INC.·00874750007066·3500C PNT/HTRSHELL/CONN ASSY

REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

DRYSTAR, MODEL 4500M

FDA 510(k)
FDA Class 2 ·Radiology

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 14, 2013

HEARTWARE® VENTRICULAR ASSIST SYSTEM

FDA Adverse Event
Malfunction ·HEARTWARE, INC·Product code DSQ·September 24, 2014

E SERIES DEFIBRILLATOR

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·May 25, 2011

XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code NIQ·March 5, 2019

Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

FDA Enforcement
Class I ·Ongoing·Covidien·November 8, 2023

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