11 results
·
34ms
·
Sources: EU EUDAMED, US FDA
ROCHE APOLIPOPROTEIN STANDARD
FDA 510(k)
FDA Class 2
·Immunology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756363624·CMC GYN LAPAROSCOPY PACK
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756104234·HAND SPLINT
PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 22, 2020
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·January 4, 2017
HERCULES 3 STAGE WIRE GUIDED BALLOON DILATOR
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code KNQ·November 19, 2010
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code DTB·July 2, 2014
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·December 3, 2012
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024