9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ANGLED FORCEP APPLIER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DUAL SHOT ALPHA
FDA 510(k)
FDA Class 2
·Cardiovascular
GAMBRO VENOUS BLOOD LINE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TFNA HELICAL BLADE L85 TAN
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HSB·March 29, 2021
RELION 31 GAUGE
FDA Adverse Event
Injury
·Product code FMF·September 30, 2012
NAVISTAR® THERMOCOOL®
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code OAD·April 24, 2014
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·July 27, 2010
TFNA HELICAL BLADE 85MM STERILE
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HSB·March 29, 2021
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024