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

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Non absorbable Surgical Polyester Suture

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

MYSPINE UNILATERAL LEFT GUIDE S01

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code PQC·August 22, 2024

TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE

FDA 510(k)
FDA Class 2 ·Orthopedic

MED-RX ORAL/ENTERAL SYRINGE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

OT VERIO PRO METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 12, 2013

AEYE-DS RETINA SCREENING

FDA Adverse Event
Injury ·AEYE HEALTH INC.·Product code PIB·January 22, 2025

HARMONIC ACE 36CM W ERG HANDLE

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code LFL·November 10, 2008

ACCESS

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MALTA·Product code KPE·September 1, 2011

PROGRAMMING SOFTWARE

FDA Adverse Event
Malfunction ·CYBERONICS INC·Product code LYJ·July 17, 2013

SECURA DR

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL, INC.·Product code LWS·August 12, 2010

INTERSTIM II

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 13, 2013

RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

FDA Enforcement
Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014