14 results · 30ms · Sources: EU EUDAMED, US FDA

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TEMPORARY COLD.V AND SELF-CURE DENTINE

FDA 510(k)
FDA Class 2 ·Dental

VANGUARD REPROCESSED ENDOSCOPIC INSTRUMENTS

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

KSEA UNIMAT 12

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

LINEAR ST

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 2, 2021

MOTO PARTIAL KNEE 02.18.IF2.08.RM TIBIAL INSERT FIX S2 RM - 8MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code HSX·March 17, 2022

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 9, 2024

STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1, SHORT NECK

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·March 15, 2022

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·April 29, 2013

ENVE

FDA Adverse Event
Injury ·CAREFUSION 203, INC.·Product code CBK·April 27, 2011

LIFEPAK 20 DEFIBRILLATOR/MONITOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC·Product code LDD·July 23, 2008

INFUSOMAT SPACE

FDA Adverse Event
Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·January 19, 2016

Z NAIL PF 14MM X 46CM UNIV Z NAIL GT 14MM X 46CM R Z NAIL GT 14MM X 46CM L Z NAIL TIBIA 14MM X 38CM UNIV Z NAIL TIBIA 14MM X 40CM UNIV Z NAIL TIBIA 14MM X 42CM UNIV Z NAIL TIBIA 14MM X 44CM UNIV

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014