17 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MUELLER-HINTON BROTH
FDA 510(k)
FDA Class 2
·Microbiology
SOLE MEDIAL COLUMN FUSION PLATE
FDA UDI
ORTHOFIX SRL·18053340347983·SS VA LOCKING SCREW L60MM D5MM
SOLE MEDIAL COLUMN FUSION PLATE
FDA UDI
ORTHOFIX SRL·18053340347617·SS VA LOCKING SCREW L60MM D5MM STERILE
FLO-ASSISTANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
3I T3¿ NON-PLATFORM SWITCHED TAPERED IMPLANT 3.25 X 11.5MM
FDA Adverse Event
Injury
·BIOMET 3I·Product code DZE·October 5, 2022
COREVALVE 31MM AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 30, 2014
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·October 22, 2012
RSVR MMT-326A 10PK PRDGM 1.8ML 13L
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code FMF·September 17, 2010
VANGUARD INTERLOK FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·May 18, 2018
XP-CR Tibial Tray - Interlok 79 mm Item # 195276
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
VANGUARD XP MEDIAL TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·May 18, 2018
ARCOM SERIES-A STANDARD PATELLA
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·May 18, 2018
VANGUARD INTERLOK FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·May 18, 2018
VANGUARD XP LATERAL TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·May 18, 2018
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017