20 results · 28ms · Sources: EU EUDAMED, US FDA

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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