BEUDAMED
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    EDEN ControlCath

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    3D Printed Interbody Systems

    FDA UDI
    Seaspine Orthopedics Corporation·10889981304171·2-Hole No-Profile Interbody, 43mm x 30mm x 14mm...

    Meridian

    FDA UDI
    Seaspine Orthopedics Corporation·10889981310059·Trial Rasp, 43mm x 30mm x 14mm, 10 Deg

    Meridian

    FDA UDI
    Seaspine Orthopedics Corporation·10889981247478·No-Profile Interbody, 43mm x 30mm x 14mm, 10 Deg

    X SERIES

    FDA UDI
    Zoll Medical Corporation·00847946019365·Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFI...

    X SERIES

    FDA UDI
    Zoll Medical Corporation·00847946006334·Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFI...

    Turbo

    FDA UDI
    SPINAL ELEMENTS·00840916118235·Turbo MIS TLIF, Titanium, 24mm long x 14 mm wid...

    PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ORAGENE DX OGD-500.001

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BD PANEL PHOENIX NMIC-311

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·January 5, 2024

    BD PHOENIX¿ NID

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code LQM·January 5, 2024

    BD PHOENIX¿ NID

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code LQM·January 5, 2024

    CMD 24-1410 PROMADE SHOULDER

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code PHX·February 28, 2025

    TRIATHLON CR FEM COMP #7 L-CEM

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·November 10, 2014

    CONSTELLATION WITH LASER

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·August 18, 2011

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 22, 2013

    BD PANEL PHOENIX NMIC-311

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·November 29, 2023

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0136-S 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 40-0137-S 3.0mm x 90mm Dual-Trak Clavicle Screw 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 40-0138-S 3.0mm x 100mm Dual-Trak Clavicle Screw 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 40-0139-S 3.0mm x 110mm Dual-Trak Clavicle Screw 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 40-0140-S 3.0mm x 120mm Dual-Trak Clavicle Screw 40-0143 3.8mm x 80mm Dual-Trak Clavicle Screw 40-0143-S 3.8mm x 80mm Dual-Trak Clavicle Screw 40-0144 3.8mm x 90mm Dual-Trak Clavicle Screw 40-0144-S 3.8mm x 90mm Dual-Trak Clavicle Screw 40-0145 3.8mm x 100mm Dual-Trak Clavicle Screw 40-0145-S 3.8mm x 100mm Dual-Trak Clavicle Screw 40-0146 3.8mm x 110mm Dual-Trak Clavicle Screw 40-0146-S 3.8mm x 110mm Dual-Trak Clavicle Screw 40-0147 3.8mm x 120mm Dual-Trak Clavicle Screw 40-0147-S 3.8mm x 120mm Dual-Trak Clavicle Screw

    FDA Enforcement
    Class II ·Ongoing·Acumed LLC·January 4, 2023

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014