11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BroncTru Transbronchial Access Tool
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Cal OSHA - 18 Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588026015·Cal OSHA - 18 Metal
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776376147·Raspatory Spatula, sharp, straight, 12x12mm, 15...
STRYKER INTERVENTIONAL PAIN RF GENERATOR
FDA 510(k)
FDA Class 2
·Neurology
COROENT STERILE IMPLANTS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING·Product code HXB·September 2, 2011
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
FDA Adverse Event
Malfunction
·COOK, INC.·Product code MIH·September 11, 2014
PROLENE POLYPROPYLENE MESH
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·July 18, 2013
Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System
FDA Enforcement
Class II
·Ongoing·Think Surgical, Inc.·March 27, 2024
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023