10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
TITAN GEL REP CPK-12 HV
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GC Initial™
FDA UDI
Gc America Inc.·15400556704339·GC Initial™ Ti Inside IN-46 Brasil, 20g
GC Initial™
FDA UDI
Gc America Inc.·J0228741461·GC Initial™ Ti Inside IN-46 Brasil, 20g
TOGGLE LOCKING PLIERS-STRAIGHT JAW, CURVED JAW
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ANTHROSCOPY SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TDX/TDXFLX CANNABINOIDS REAGENT
FDA Adverse Event
Injury
·ABBOTT HEALTH PRODUCTS, INC.·Product code LDJ·November 8, 2006
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 16, 2014
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 19, 2010
PRIMEADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 14, 2012
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024