BEUDAMED
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    ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    n/a

    FDA UDI
    Ortho Development Corporation·00822409089048·Dual Offset Inserter Right

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR21010171·Roncone PDS .017"x.025" Beta Titanium Size 32 U...

    Entrada Hip Stem

    FDA UDI
    Ortho Development Corporation·00822409036158·Size 17 EXT Collarless

    Wire Speculum

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896115132·Wire Speculum Closed Blades 18 Millimeter Sprea...

    Ophthlamic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668115541·INFANT SPECULUM 4MM SOLID (10/BX)

    TLS2 14C

    FDA Adverse Event
    Malfunction ·MICROLINE SURGICAL INC.·Product code GEI·November 27, 2012

    PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MC, MICROCURRENT

    FDA 510(k)
    FDA Class 2 ·Neurology

    RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DELTAFILL18 8MM X 35CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·July 29, 2020

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 29, 2025

    AccuSITE Needle Guide

    FDA UDI
    CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436101643·Sterile needle guide with (14 x 147cm) telescop...

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 8, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 19, 2014

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING·Product code LXH·May 24, 2011

    BATTERY RECIPROCATOR II FOR BPL II

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code GEY·April 15, 2024

    3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains instrumentation for the implantation of the FibuLock implant. Contents include: Actuation Driver, 6.2mm Reamer, 3.2mm Reamer, 2 mm Drill, Spade Tip Guide Wire, and 1.6mm x 12 K-Wire.

    FDA Enforcement
    Class II ·Ongoing·Arthrex, Inc.·November 21, 2018

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·December 8, 2017

    Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 2013

    Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3, 61106; DUREPAIR DURA SUBSTITUTE 4 X 5, 61110; DUREPAIR DURA SUBSTITUTE 1 X 1, 61111; DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE, 62100; DURA 62105 SUBSTITUTE DUREPAIR 3X3IN NCE, 62105; DURA 62106 SUBSTITUTE DUREPAIR 1X3IN NCE, 62106; DURA 62110 SUBSTITUTE DUREPAIR 4X5IN NCE, 62110; DURA 62111 SUBSTITUTE DUREPAIR 1X1IN NCE, 62111; DURA 62158 SUBSTITUTE DUREPAIR 5X8IN NCE, 62158.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neurosurgery·July 26, 2023