11 results
·
23ms
·
Sources: EU EUDAMED, US FDA
ARTAP ARTERIAL BLOOD SAMPLING DEVICE
FDA 510(k)
FDA Class 1
·Anesthesiology
LnK Cervical Interbody Fusion Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
IMT.LAB
FDA 510(k)
FDA Class 2
·Radiology
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 14, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 23, 2012
TOTAL ASR ACET IMP SIZE 62
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·June 15, 2015
BIOMET ILOK PRI TIB TRAY 63MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·May 5, 2022
BMET ARCOM AP PAT W/WIRE 31MM IRE 31MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·May 5, 2022
VANGUARD CR ILOK FEM-LT 60 60
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·May 5, 2022
VNGD CR TIB BRG 12X63/67 MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·May 5, 2022
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262
FDA Enforcement
Class II
·Terminated·Isopure Corp·September 21, 2022