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

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    EzFuze Implant System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HHM

    FDA UDI
    Oticon A/S·05707131286369·H160V2 TI, MINIRITE 312 WL STG HHM

    Accent Buccal Tube

    FDA UDI
    ORMCO CORPORATION·00889989054019·ACCENT B/T 5SGL 2ND WDX -10TX22 UL

    PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH ALOE VERA

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PERSONAL WARMING GEL

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SPECTRANETICS QUICK-CROSS SUPPORT CATHETER

    FDA Adverse Event
    Injury ·THE SPECTRANETICS CORPORATION·Product code DQY·March 6, 2019

    OT VERIO FLEX METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 1, 2015

    PAINSMART IOD

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·May 29, 2013

    CONICAL EXTRACTION SCREW

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HWC·June 10, 2011

    LAB-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    FDA Adverse Event
    Injury ·BIOENTERICS CORP.·Product code LTI·September 3, 2008

    6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·June 1, 2017

    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

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015