BEUDAMED
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    PHYSIOSTAR NFC

    FDA 510(k)
    FDA Class 2 ·Dental

    Flextra Steerable Introducer

    FDA UDI
    RHYTHM XIENCE, INC.·00852392007019·Flextra - 65cm - MED Curl Flextra Steerable Int...

    AcQGuide

    FDA UDI
    ACUTUS MEDICAL, INC.·00857042007456·AcQGuide Flex 65 cm Med Curl with AcQCross QX

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970546·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970553·

    BABI PLUS NEONATAL RESUSCITATION BAG

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ZIRCONIA BLANKS (ZIRCOSTAR)

    FDA 510(k)
    FDA Class 2 ·Dental

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 21, 2013

    ASR ACETABULAR CUPS 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 3, 2011

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·August 14, 2008

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·November 25, 2024

    Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly

    FDA Enforcement
    Class II ·Terminated·Acutus Medical Inc·April 29, 2020

    Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle, REF: 122852, SterileEO RxOnly

    FDA Enforcement
    Class II ·Terminated·Acutus Medical Inc·April 29, 2020

    Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly

    FDA Recall
    Terminated ·Acutus Medical Inc·Product code DYB·February 25, 2020

    Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle, REF: 122852, SterileEO RxOnly

    FDA Recall
    Terminated ·Acutus Medical Inc·Product code DYB·February 25, 2020

    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

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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