10 results
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20ms
·
Sources: EU EUDAMED, US FDA
SCANLAN VASCU-STATT II APPROXIMATOR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SOLE MEDIAL COLUMN FUSION PLATE
FDA UDI
ORTHOFIX SRL·18053340347839·SS VA LOCKING SCREW L14MM D5MM
SOLE MEDIAL COLUMN FUSION PLATE
FDA UDI
ORTHOFIX SRL·18053340346719·SS VA LOCKING SCREW L14MM D5MM STERILE
TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYNAPSE 3D TENSOR ANALYSIS
FDA 510(k)
FDA Class 2
·Radiology
ECHELON LINEAR CUTTER RELOAD
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 30, 2014
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 22, 2012
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 14, 2010
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
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024