BEUDAMED
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    K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Cannulated Headless Compression Screw, 1/4 Threaded, 3.5mm x 70mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665025071·

    iDuo G2 TRAY BASE, PATELLA INSTRUMENTS

    FDA UDI
    Conformis, Inc.·00850268007354·

    Berman Airways

    FDA UDI
    MERCURY ENTERPRISES, INC.·10641043800706·

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014604275·ARMBOARD REGULAR, PAD 4"

    DIAMOND CARPAL

    FDA UDI
    Stryker GmbH·00886385006659·Drill Guide, 1.5mm Compressing

    AXS INFINITY LS

    FDA UDI
    Stryker Corporation·07613327298246·Long Sheath

    ELECTRO SURGICAL INSTRUMENT COMPANY

    FDA Adverse Event
    Other ·ELECTRO SURGICAL INSTRUMENT COMPANY·Product code FDG·January 22, 2013

    Persona® PPS®

    FDA UDI
    Zimmer, Inc.·00889024631205·

    Persona® PPS®

    FDA UDI
    Zimmer, Inc.·00889024631199·

    FLOCATH

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

    ULTRAPAK NEHA

    FDA 510(k)
    FDA Unclassified ·Unknown

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 5, 2024

    HLM TUBING SET W/BIOLINE COATING

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DWE·March 25, 2016

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·April 26, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·April 6, 2011

    POLYFLUX LR CAPILLARY DIALYZER

    FDA Adverse Event
    Malfunction ·GAMBRO DIALYSATOREN GMBH·Product code MSF·July 24, 2008

    AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made in Ireland, Sterile EO. The AXS Infinity LS Long Sheath system contents are: One (1) AXS Infinity LS Long Sheath, One (1) Hemostasis valve with extension tubing, One Long Dilator.

    FDA Recall
    Terminated ·Stryker Neurovascular·Product code DQY·May 2, 2018

    AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made in Ireland, Sterile EO. The AXS Infinity LS Long Sheath system contents are: One (1) AXS Infinity LS Long Sheath, One (1) Hemostasis valve with extension tubing, One Long Dilator.

    FDA Enforcement
    Class II ·Terminated·Stryker Neurovascular·October 10, 2018

    GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016