BEUDAMED
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    OBSIDIAN CERAMIC BLOCKS

    FDA 510(k)
    FDA Class 2 ·Dental

    Osstell SmartPeg Type 108

    FDA UDI
    Osstell AB·09010522002278·ISQ Measurement Peg

    MICHEL CLIP APPLIER/REMOVER FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896090675·MICHEL CLIP APPLIER/REMOVER FORCEPS

    DEBAKEY SATINSKY CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09921007810·DEBAKEY SATINSKY CLAMP DOUBLE ANGLED JAW

    DEBAKEY SATINSKY CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896003408·DEBAKEY SATINSKY CLAMP DOUBLE ANGLED JAW

    Medallion®

    FDA UDI
    Merit Medical Systems, Inc.·00884450096154·

    Indus®

    FDA UDI
    SPINEFRONTIER, INC.·00190361001485·Invue Max, Four Level ACP, 81mm

    N/A

    FDA UDI
    Doppkon GmbH & Co. KG·04262494463914·Curette forward angled D 4.5mm, L 7mm, WL 120mm

    CEEON

    FDA Adverse Event
    Injury ·PHARMACIA & UPJOHN, GRONINGEN·Product code HQL·November 5, 2001

    3M ESPE HAUR

    FDA 510(k)
    FDA Class 2 ·Dental

    DIRECT TIBC KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 8, 2013

    RESERVOIR 1.8ML

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code FRN·September 16, 2014

    QUATTRODE LEAD, 3/4MM, 90 CM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 19, 2011

    Brilliance iCT Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·January 24, 2018

    Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018

    TherMax Blood Warmer Unit

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·November 6, 2019

    Brilliance iCT - Model 728306 Computed Tomography X-ray systems

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·January 31, 2018

    IVEA Product Part Number 16100 Model 500A

    FDA Enforcement
    Class II ·Terminated·Firefly Medical, Inc.·October 11, 2017

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020