7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
UROLOGICAL BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Death
·ZOLL LIFECOR CORPORATION·Product code MVK·February 15, 2013
LIGASURE IMPACT
FDA Adverse Event
Malfunction
·COVIDIEN VALLEYLAB·Product code GEI·January 26, 2011
11MM TI CANN TIBIAL NAIL-EX W/PROX BEND 360MM-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code JDS·August 5, 2014
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024