BEUDAMED
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    DR GREENBURGS HYBRID ACRYLIC

    FDA 510(k)
    FDA Class 2 ·Dental

    BullDog®

    FDA UDI
    DIVERSATEK HEALTHCARE, INC.·00816734021330·Disposable Endoscope Valves Set

    SPY INTRA-OPERATIVE IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    UPLINK TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    FREESTYLE PRECISION NEO

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·January 10, 2017

    ASR ACETABULAR IMPLANT 60

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·May 20, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 10, 2011

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/10 MM LEFT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 7, 2016

    Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve, Biopsy Valve Manufactured for: Diversatek Healthcare 102 E.Keefe Ave. Milwaukee, WI 53212 USA Product Code: 1203-71

    FDA Enforcement
    Class II ·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020

    Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve, Biopsy Valve Manufactured for: Diversatek Healthcare 102 E.Keefe Ave. Milwaukee, WI 53212 USA Product Code: 1203-71

    FDA Recall
    Terminated ·GA HEALTH COMPANY LIMITED Unit 18, 21/F Metropole Square; 2 On Yiu Street ,Shatin, N.T Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020

    AlignRT Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.

    FDA Recall
    Terminated ·Vision RT Ltd Dove House, Arcadia Avenue London United Kingdom·Product code IYE·June 30, 2016

    AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·August 31, 2016

    MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.

    FDA Enforcement
    Class II ·Terminated·Medrad Inc·February 27, 2013

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015