14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHES 2.0 MM LOCKING PLATE SYSTEM (2.0 LPS)
FDA 510(k)
FDA Class 2
·Dental
Stainless Steel Tibial Nailing System
FDA UDI
ORTHOFIX SRL·18033509851162·REVISION LOCKING SCREW STERILE THREAD D 8 MM L...
KEELER ACU 22XT OPHTHALMIC CRYO UNIT
FDA 510(k)
FDA Class 2
·Ophthalmic
DURAFILL FLOW
FDA 510(k)
FDA Class 2
·Dental
PSO KNEE BONE SUBSTITUTION
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code KRO·April 22, 2022
1.5MM RESORB ORBITAL FLOOR PL 24MMX24MM W/BENDING TEMP-STER
FDA Adverse Event
Injury
·SYNTHES USA·Product code JEY·November 2, 2012
PSO KNEE BONE SUBSTITUTION
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code KRO·July 18, 2019
CURLIN INFUSION IV PUMP
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP·Product code FRN·January 29, 2013
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 31, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 3, 2014
UNKNOWN HEAD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·February 16, 2018
BD PYXIS¿ MEDSTATION¿ ES
FDA Adverse Event
Malfunction
·CAREFUSION 303, INC.·Product code BRY·March 31, 2025
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H, 145DX16H, 145DX18H, 145DX20H, 150DX16H, 150DX18H, 150DX20H
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017