BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    V80 Anesthetic Vaporizer (V80)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Medline Industries, Inc.

    FDA UDI
    MEDLINE INDUSTRIES, INC.·10889942004843·COLD PREVENT KIT

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257130070·30-40 MV FOR MEN CLSC EW STD NAVY V

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017972·K-Wire, Single Ended, Trocar Point, Diameter Si...

    ORTHOFIX

    FDA UDI
    ORTHOFIX SRL·18059015375374·REVISION LOCKING SCREW L37.5MM D4.0MM

    ORTHOFIX

    FDA UDI
    ORTHOFIX SRL·18059015374872·REVISION LOCKING SCREW L37.5MM D4.0MM STERILE

    ACCU-CHEK AVIVA

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS CORP.·Product code NBW·February 3, 2006

    MASTERGRAFT PUTTY, MASTERGRAFT STRIP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IDEAL 1 ORTHODONTIC BAND CEMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    RAYONE EMV

    FDA Adverse Event
    Malfunction ·RAYNER INTRAOCULAR LENSES LIMITED·Product code HQL·March 3, 2024

    COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 25, 2008

    PASSIVE PLUS DX

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011

    3MM FLUTED BALL, STD

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013

    Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239

    FDA Enforcement
    Class I ·Ongoing·Bard Peripheral Vascular Inc·March 12, 2025

    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

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014