BEUDAMED
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    I-MINI DENTAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Dental

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756002714·Wrist Splint

    n/a

    FDA UDI
    Ortho Development Corporation·00822409075171·Distal Reamer 11.5mm

    Conformis Hip System

    FDA UDI
    Conformis, Inc.·00850268007880·ITOTAL HIP INSTRUMENT CASE, REAMERS

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014604596·LATERAL BRACE PAD, 6' DIA X 2" DELUX- SLIP POCKET

    Track A

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR4080115·Track A ø 1,5 x 125 mm

    Symmetry Malis®

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482140062·Symmetry® Bipolar Forceps; Straight; Titanium; ...

    General Instrument

    FDA UDI
    ALPHATEC SPINE, INC.·00840180506738·Longer Rotating Distractor, Holed, 15mm

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197029094·Iris Scissors straig...

    NA

    FDA UDI
    STRYKER CORPORATION·07613327052145·Bipolar Micro-Tip Forceps with Spring Handle

    REFLEX ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RETIC CHEX LINEARITY

    FDA 510(k)
    FDA Class 2 ·Hematology

    CUSTOM CONVENIENCE KIT

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code BYX·June 29, 2005

    SMARTSET MV 40G - EO

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LOD·October 18, 2019

    DURATA STS OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·April 26, 2013

    HEDSTROEM FILE

    FDA Adverse Event
    Malfunction ·DENTSPLY TULSA DENTAL SPECIALTIES·Product code EKS·April 6, 2011

    PINNACLE SECTOR II CUP 58MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·July 18, 2008

    PK DISSECTING FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·August 26, 2013

    Cocoon Convective Warming System, Product Code: CWS4000 (110V).

    FDA Enforcement
    Class II ·Terminated·Care Essentials Pty., Ltd.·February 12, 2020

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014