10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue
FDA 510(k)
FDA Class 2
·Dental
NitriTec Vinyl Glove Powder Free Blue
FDA 510(k)
FDA Class 1
·General Hospital
Laser Thermal Therapy Kit
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 22, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·November 18, 2014
GYNECARE TVT OBTURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·August 1, 2013
BIPLATE SCHAEDLER/SCHAED KV 5% SB 20
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSJ·June 25, 2021
BD BBL¿ SCHAEDLER K-V AGAR WITH 5% SHEEP BLOOD
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSJ·August 2, 2021
BIPLATE SCHAEDLER/SCHAED KV 5% SB 20
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSJ·July 1, 2021
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