20 results
·
28ms
·
Sources: EU EUDAMED, US FDA
ITC BUNJI COIL
FDA 510(k)
FDA Class 2
·Neurology
8MM BONE DOWEL PLUNGER
FDA UDI
Biomet Orthopedics, LLC·00880304401723·
Bone Dowel Plunger
FDA UDI
Biomet Orthopedics, LLC·00887868510786·
Lower Crown Pack for Herbst LL6 12mm
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199007230·
NA
FDA UDI
Synthes GmbH·10886982256348·2.5MM THREADED GUIDE WIRE SPADE POINT 230MM
HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5,
FDA 510(k)
FDA Class 2
·Dental
GEENEN PANCREATIC STENT SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·January 10, 2019
GMK-HINGE TIBIAL INSERT - SIZE3 - 12 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·March 1, 2024
VIRTUOSO VR
FDA Adverse Event
Death
·IPG MFG SWITZERLAND·Product code LWS·June 27, 2014
M2A-MAGNUM MOD HD SZ 54MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·January 8, 2013
FREESTYLE FREEDOM LITE
FDA Adverse Event
Injury
·Product code NBW·November 16, 2010
POLIGRIP ADH CREAM FREE 2.4OZ, SKU 900334 POLIGRIP DENTURE ADHESIVE ORIGINAL 2.4OZ, SKU 900723 SUPER POLIGRIP ADH CREAM .75OZ, SKU 900085
FDA Enforcement
Class II
·Ongoing·Family Dollar Stores, Llc.·August 24, 2022
GEENEN PANCREATIC STENT
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code FGE·September 14, 2018
GEENEN PANCREATIC STENT
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code FGE·September 14, 2018
GEENEN PANCREATIC STENT
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code FGE·September 14, 2018
POLIGRIP ADH CREAM FREE 2.4OZ, SKU 900334 POLIGRIP DENTURE ADHESIVE ORIGINAL 2.4OZ, SKU 900723 SUPER POLIGRIP ADH CREAM .75OZ, SKU 900085
FDA Recall
Open, Classified
·Family Dollar Stores, Llc.·Product code KOO·June 23, 2022
UNKNOWN
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·June 9, 2021
ZIMMON PANCREATIC STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·October 16, 2020
Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 8, 2017