19 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AQUILION PRIME, V5.00
FDA 510(k)
FDA Class 2
·Radiology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776303631·Farrior Spec Oval Oblique 4.5mm Ebonized
EVONOS
FDA UDI
Gyrus ACMI, LLC·00821925014787·EAR SURGERY SPECULUM ROUND 4.5MM
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450184820·
MILLENNIUM
FDA UDI
Avalign Technologies, Inc.·00190776317560·Farrior Speculum
Adler Instrument Company
FDA UDI
Adler, Inc.·00810123206506·Farrior Ear Spec 4.5 mm ss
AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE
FDA 510(k)
FDA Class 2
·Cardiovascular
BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SET, ADMINISTRATION, INTRAVASCULAR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·June 6, 2016
STOPCOCK MANIFOLD GANGS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FMG·June 17, 2020
TENSION HOLDER F/TEMP-USE
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code LXH·May 24, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·September 30, 2014
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·June 14, 2011
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·November 2, 2023
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·October 19, 2023
WAVEWRITER ALPHA? PRIME
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 19, 2026
Universal Nerve Block Tray Catalog Number: 9779
FDA Enforcement
Class II
·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022
HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012