10 results · 20ms · Sources: EU EUDAMED, US FDA

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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