14 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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