13 results
·
19ms
·
Sources: EU EUDAMED, US FDA
CYSTIC DUCT BALLOON DILATING CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Polystar Selection EDITION HD
FDA UDI
Merz Dental GmbH·D7091983154·posteriors; shade BL4; size L; upper jaw
SM Electrodes
FDA 510(k)
FDA Class 2
·Neurology
NEWDEAL HALLU LOCK PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NV PRM 1LWR CLV 100"
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code FPA·August 7, 2003
ACT ARTIC E1 HIP BRG 28X54MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWY·May 30, 2019
CER BIOLOXD MOD HD 28MM -3 NK
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LZO·May 30, 2019
PROMUS ELEMENT ¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·February 28, 2013
ASR UNI FEMORAL IMPL SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·January 31, 2011
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·July 3, 2014
G7 DUAL MOBILITY LINER 54MM I
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWY·May 30, 2019
BELIFU
FDA Adverse Event
Injury
·HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED·Product code GZJ·February 10, 2020
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024