21 results · 20ms · Sources: EU EUDAMED, US FDA

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IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT

FDA 510(k)
FDA Class 2 ·Immunology

2870 3WAY SLIDE VALVE

FDA UDI
HANS RUDOLPH, INC.·00874750009008·2870K 3WAY MAN SLD VLV 1.125OD

Disc Prep

FDA UDI
Life Spine, Inc.·00190837090074·

Tandry Locking Plate System

FDA UDI
MICROWARE PRECISION CO., LTD.·04719873105939·3.5mm Locking Medial Distal Tibial Plate, 10 Ho...

MULTI-LEAD TRIALING CABLE MODEL 355531

FDA 510(k)
FDA Class 2 ·Neurology

REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS

FDA 510(k)
FDA Class 2 ·Cardiovascular

ECHI GREENVILLE NC 2

FDA Adverse Event
Other ·SORIN GROUP USA, INC.·Product code DTZ·November 22, 2011

ECHI GREENVILLE NC 2

FDA Adverse Event
Other ·SORIN GROUP USA, INC.·Product code DTZ·November 30, 2011

STONYBROOK HSP NY NY 1

FDA Adverse Event
Other ·SORIN GROUP USA, INC.·Product code OEZ·September 15, 2015

ASR 300 SPIKED CUP SIZE 54

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·May 14, 2013

LIFEPAK 20E DEFIBRILLATOR/MONITOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·August 11, 2008

GOBED II

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·May 25, 2011

C21785 IT TREVISO

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code GEI·December 14, 2012

D731 MICRO 27 ARTERIAL FILTER WITH 27 MICRON PHISIO COATING

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTM·May 18, 2022

BD PYXIS¿ ANESTHESIA STATION ES

FDA Adverse Event
Malfunction ·CAREFUSION 303, INC.·Product code BRY·July 17, 2025

WALLFLEX? BILIARY TRANSHEPATIC

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - GALWAY·Product code FGE·August 21, 2012

D731 MICRO 27 ARTERIAL FILTER WITH 27 MICRON PHISIO COATING

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTM·March 17, 2022

Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

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

ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026