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

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Astroglide Organix Liquid

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

Drill Guide

FDA UDI
Treace Medical Concepts, Inc.·00810111221689·Drill Guide and Template

DEBAKEY FORCEPS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896060074·DEBAKEY FORCEPS

Bradshaw Medical Inc.

FDA UDI
Bradshaw Medical, Inc.·00810019930157·BIT, HEX MALE 5/32" AO

NA

FDA UDI
G & H Wire Company, Inc.·10190886246597·DISTAL SEGMENT - 19mm MINISCOPE COMPONENT RIGHT

3D KNEE

FDA 510(k)
FDA Class 2 ·Orthopedic

RS-4M+MUSCLE STIMULATOR

FDA 510(k)
FDA Class 2 ·Physical Medicine

Widex

FDA UDI
Widex A/S·05706069883022·WIDEX MOMENT MRB2D (Honey blond ) Telecoil, RIC...

XEN 45 GTS

FDA Adverse Event
Injury ·ALLERGAN (IRVINE)·Product code KYF·August 11, 2022

Olympus Fluid Aspiration Set; a sterile set of silicone tubing and connectors for use with the Olympus SP-2 Fluid Irrigation & Aspiration Pump; 10 sets per box; Manufactured for: Olympus America Inc., Two Corporate Center Drive, Melville, NY 11747-3157; catalog #72-00114-0 The fluid aspiration set is used in conjunction with the Olympus SP-2 pump for fluid aspiration during urological endoscopic procedures or laparoscopic procedures.

FDA Recall
Terminated ·Northgate Technologies, Inc.·Product code KQT·July 25, 2011

PROLIEVE THERMODILITATION SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MEQ·October 15, 2008

PERISTEEN BAG/RECTAL CATHETERS

FDA Adverse Event
Injury ·COLOPLAST A/S·Product code KNT·August 10, 2011

ACCU-CHEK ® MOBILE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 1, 2013

TALENT THORACIC STENT GRAFT

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·June 23, 2011

U0308 XENIUM 210G SYNTH HFDIALYZER

FDA Adverse Event
Injury ·NIPRO CORP·Product code KDI·December 2, 2008

TALENT THORACIC STENT GRAFT

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·June 23, 2011

Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support for the care of individuals

FDA Enforcement
Class I ·Ongoing·Baxter Healthcare Corporation·March 8, 2023

ANIMAS INSULIN CARTRIDGE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·February 29, 2016

SYNVISC (HYLAN G-F 20) INJECTION

FDA Adverse Event
Other ·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·April 25, 2013

HOMECHOICE CYCLER-REFURBISHED

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 8, 2010