BEUDAMED
    18 results · 20ms · Sources: EU EUDAMED, US FDA

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    WURTZ CHOLEY CLIP (TM)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Map-iT

    FDA UDI
    ACCESS POINT TECHNOLOGIES, INC.·00818083011253·Fixed, 10 electrode, HIS, 2-5-2mm electrode spa...

    SURGICAL WIDE FIELD LENS WITH HANDLE

    FDA UDI
    KATENA PRODUCTS, INC.·00841668111789·

    Mini Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746110870·DB BKT MINI MS LL CUSP 018 T-6 A+3 R=0

    ALPHA OMEGA DUAL COOLER-HEATER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    10.0 MM FLIP CUTTER II

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code MDM·June 30, 2014

    EMAX 2 PLUS MOTOR

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBE·January 3, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·November 17, 2010

    GENERATOR PULSAR II

    FDA Adverse Event
    Injury ·MEDTRONIC ADVANCED ENERGY (SALIENT)·Product code GEI·November 23, 2016

    GENERATOR PULSAR II

    FDA Adverse Event
    Injury ·MEDTRONIC ADVANCED ENERGY (SALIENT)·Product code GEI·October 7, 2016

    Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901520, 15mm, 5.5mm dia x 120mm, size: 15mm x 120mm, for spinal fixation.

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code NQP·November 12, 2007

    Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 460 mm, Item Number: 814513460

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 19, 2018

    Ingenuity Core 128, model #728323; Intended to produce cross- sectional images of the body.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 6, 2016

    Comprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Product Usage: N/A

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·April 10, 2019