14 results
·
18ms
·
Sources: EU EUDAMED, US FDA
TEMPERLITE(TM) SAW BLADE
FDA 510(k)
FDA Class 2
·Orthopedic
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756020893·FINGER SPLINTS
Votion®
FDA UDI
Ortho Organizers, Inc.·00190707114282·Votion .018 R UR 4/5 -7T 0A 2DO (10PK) VOTION
Pinnacle
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730010414·Pinnacle .018 R UR 4/5 -7T 0A 2DO (10PK)
Votion
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730008589·Votion .018 R UR 4/5 -7T 0A 2DO (10PK)
Pinnacle®
FDA UDI
Ortho Organizers, Inc.·00190707112370·Pinnacle .018 R UR 4/5 -7T 0A 2DO (10PK) PINNACLE
Razor, Everest, U&C Liquid
FDA 510(k)
FDA Class 2
·Dental
AEQUALIS SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VITEK® 2 AST-P626 TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·December 12, 2018
VITEK® 2 AST-P626 TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·December 13, 2018
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 13, 2014
RSVR MMT-332A 10PK PRDGM 3CC 14L
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code FMF·November 24, 2010
THINLINE II
FDA Adverse Event
Injury
·GUIDANT ANGLETON/ST. PAUL·Product code NVN·January 11, 2013
GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000
FDA Enforcement
Class I
·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024