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

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    SmartGuard Anti-Snoring Device

    FDA 510(k)
    FDA Class 2 ·Dental

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925047365·Digital Hub, ES-IP

    25M - First Aid Kit - Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588060576·25M - First Aid Kit - Metal

    CALIPER CASTROVIEJO 40MM LONG STRAIGHT FOR IMPLANTS

    FDA UDI
    W.H. Holden, Inc.·D9282006570·

    Apelo® / Apelo® MIS

    FDA UDI
    ATLAS SPINE, INC.·M68120065700000·Right In-Situ Bender

    LUER ACCESS UNIVERSAL VIAL ADAPTER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ACCULASER PRO LOW LEVEL LASER THERAPY DEVICE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    GENTLEPOWER LUX CONTRA ANGLE 25LPA

    FDA Adverse Event
    Injury ·KALTENBACH & VOIGT GMBH·Product code EFB·October 20, 2008

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·August 11, 2011

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 1, 2013

    ENDOPATH

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 18, 2017

    Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Receiver (mg/dL), Pink (pediatrics); MT22608-BLU, Receiver (mg/dL), Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·October 13, 2021

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021