14 results · 24ms · Sources: EU EUDAMED, US FDA

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AMICUS Separator System

FDA 510(k)
FDA Unclassified ·Unknown

Sonic

FDA UDI
Sonic Innovations, Inc.·05711583033006·ET20, KIT 312 NFM 85 PB T R BE ENCHANT 20

Integra® Miltex®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780419150·Integra® Miltex® Bellucci Micro Ear Scissors 3"...

SYNGO DYNAMICS, VERSION 9.0

FDA 510(k)
FDA Class 2 ·Radiology

COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT

FDA 510(k)
FDA Class 2 ·Orthopedic

DUETTO MT

FDA Adverse Event
Malfunction ·QUANTA SYSTEM S.P.A.·Product code GEX·April 14, 2022

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 7, 2014

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 8, 2014

TENDRIL ST

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code NVN·January 13, 2014

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·August 4, 2011

ACCU-CHEK SPIRIT COMBO

FDA Adverse Event
Injury ·ROCHE DIABETES CARE AG·Product code LZG·June 27, 2013

NV GXL LNR, LIPPED 32MM ID GROUP 2 CUPS

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JDI·April 22, 2024

Total Knee Junior Model Number 1100 Product Usage: The Total Knee Junior is an external polycentric prosthetic knee with a geometric locking system.

FDA Recall
Terminated ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISY·August 10, 2009

bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, REF 378212 (c) 115mm, 45o, REF 378231 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

FDA Enforcement
Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018