BEUDAMED
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    WILLI GELLER CREATION & AV PORCELAIN

    FDA 510(k)
    FDA Class 2 ·Dental

    X-Trans® HB-1 Armboard

    FDA UDI
    Qfix·10841962110256·X-Trans Armboards: HB-1 Armboard

    ZEVO™ Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169329980·PLATE 3002041 ZEVO 41MM 2 LVL

    Essential Kit

    FDA UDI
    MEDIVATORS INC.·40677964018204·Essential Kit includes Drawstring Transport Pad...

    ZEVO™ Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00763000663544·PLATE 3002041 ZEVO 41MM 2 LVL

    Astra®-compatible

    FDA UDI
    Preat Corporation·00842092181454·Titanium Scan Body for Astra®-compatible 3.0mm

    X-Trans™ HB-1 Armboard

    FDA UDI
    Qfix·10841962109625·X-Trans Armboards: HB-1 Armboard

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092002041·artVeneer life lower posteriors, XL, A4

    MINIMUM ESSENTIAL MEDIUM EAGLE(MEM) CAT.#200-2041

    FDA 510(k)
    FDA Class 1 ·Hematology

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    FDA Adverse Event
    Malfunction ·HAMILTON BONADUZ AG·Product code JTC·May 24, 2000

    RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AGC-GOLD ELECTROLYTE FOR AGC-MICRO, AGC-GOLD ELECTROLYTE FOR AGC-SPEED, AGC-GOLDBONDER, AGC GLAVANOGOLD

    FDA 510(k)
    FDA Class 2 ·Dental

    VACUUM REGULATOR

    FDA Adverse Event
    Malfunction ·ALLIED HEALTHCARE PRODUCTS, INC.·Product code KDP·February 12, 2013

    HEARTSTART XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 3, 2014

    CRYSTALENS

    FDA Adverse Event
    Injury ·EYEONICS, INC.·Product code HQL·February 25, 2008

    OXF ANAT BRG LT MD SIZE 6 PMA

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·April 2, 2020

    OXF UNI TIB TRAY SZ C LM PMA

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·April 2, 2020

    QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.

    FDA Enforcement
    Class II ·Terminated·Qiagen Sciences LLC·March 18, 2020

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022