20 results · 31ms · Sources: EU EUDAMED, US FDA

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X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)

FDA 510(k)
FDA Class 2 ·Radiology

DJO SURGICAL

FDA UDI
Encore Medical, L.P.·00190446929734·SPECIAL, TAPERFILL BIPOLAR TRIALS, NEUTRAL OFFS...

StarDental Instrument Solutions

FDA UDI
DENTALEZ, INC.·D7022019320·INSTR MG DE GOLDMAN-FOX 4

NA

FDA UDI
Synthes GmbH·20887587028658·2.0MM IMF SCREW SELF-DRILLING 12MM

SYNTHES 6.5 MM CANNULATED SCREW

FDA 510(k)
FDA Class 2 ·Orthopedic

TORNIER CEMENT RESTRICTOR

FDA 510(k)
FDA Class 2 ·Orthopedic

QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199

FDA 510(k)
FDA Class 1 ·Microbiology

VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAM·March 17, 2020

RESTELLA

FDA Adverse Event
Injury ·AROA BIOSURGERY·Product code FTM·December 4, 2019

RESOLUTE ONYX OTW

FDA Adverse Event
Malfunction ·MEDTRONIC IRELAND·Product code NIQ·July 5, 2019

DESARA

FDA Adverse Event
Injury ·CALDERA MEDICAL, INC.·Product code FTL·October 20, 2014

SPRINT QUATTRO SECURE

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011

INTERSTIM

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·July 2, 2013

HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

FDA Adverse Event
Injury ·HEARTWARE, INC.·Product code DSQ·April 21, 2020

VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAM·January 2, 2020

UNK - CONSTRUCTS: LCP

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code HRS·May 15, 2026

HEARTWARE VENTRICULAR ASSIST SYSTEM-OUTFLOW GRAFT

FDA Adverse Event
Injury ·HEARTWARE, INC.·Product code DSQ·June 13, 2019

HEARTWARE® VENTRICULAR ASSIST SYSTEM - PUMP

FDA Adverse Event
Injury ·HEARTWARE, INC.·Product code DSQ·June 26, 2019

CHAIT PERCUTANEOUS CECOSTOMY CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code KNT·April 17, 2023

EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021