12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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