BEUDAMED
    18 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 ×

    ASAHI SION PTCA GUIDE WIRE MODEL AHW14R001S & AHW14R301S

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Medi-First Plus Flexible Knuckle HW

    FDA UDI
    Medique Products·00347682105785·A flexible band of fabric material coated on on...

    OptiBite Disposable Biopsy Forceps

    FDA UDI
    Micro-Tech (Nanjing) Co., Ltd.·06932503540384·Normal handle, Oval, without spike, Single out...

    JEURS LEMPERT NEUROLOGIC RONGEUR

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896048133·JEURS LEMPERT NEUROLOGIC RONGEUR CURVED TO SIDE...

    BREG

    FDA UDI
    BREG, INC.·00672736134009·1 Ice Water Container, 1 12 VDC output and 240 ...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450525791·

    HS Stand. Burr, Ø2.3x95, 80k

    FDA UDI
    Bien-Air Surgery SA·17630055507195·

    QUANTA SYSTEM S.P.A.

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM, S.P.A.·Product code GEX·December 21, 2012

    TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SERIM LEUKOCYTE ESTERASE TEST STRIPS

    FDA 510(k)
    FDA Class 1 ·Hematology

    OXYGENATOR, CARDIOPULMONARY BYPASS

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·July 15, 2015

    BLOOD GLUCOSE SYSTEM

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·September 24, 2015

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 19, 2014

    TERUMO PERFUSION SYSTEM 8000

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code JOR·May 13, 2011

    MICROCLAVE CLEAR CONNECTOR

    FDA Adverse Event
    Malfunction ·ICU MEDICAL, INC.·Product code FPA·June 5, 2014

    Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For cardiac surgery in combination with a heart lung machine to oxygenate blood, remove carbon dioxide and adjust blood temperature.

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular Us Sales, Llc·December 31, 2014

    1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Telephone # +1 201-831-5000 Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France Intended for cementless application in total or hemiarthroplasty procedures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·December 18, 2013

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020