BEUDAMED
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    Sidecar External Working Channel

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486018306·MCK 12mm ONLAY INSERT CADDY

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100028·BLUMENTHAL SPECULUM X-HEAVY

    Tibial Offset Cutting Block : SIZE Right 7

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215056957·

    BLOOD-PRESSURE METER, BPW120

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ESTHETICA

    FDA 510(k)
    FDA Class 2 ·Dental

    RESPIRONICS

    FDA Adverse Event
    Malfunction ·Product code MNT·April 8, 2021

    ALYTE Y-MESH GRAFT

    FDA Adverse Event
    Injury ·BARD SHANNON LTD.·Product code OTO·May 31, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 5, 2011

    RADLINK

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code LNX·August 6, 2008

    TORNIER PERFORM ANATOMIC AUG MED RIGHT GLENOID 15 DG

    FDA Adverse Event
    Injury ·TORNIER INC·Product code KWS·March 8, 2024

    Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. ¿¿¿

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·November 25, 2015

    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