BEUDAMED
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    SWIFT FX

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Laparoscopy Set for ROCAFLOW - 2 ways

    FDA UDI
    Promepla·03700512901976·

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036028121·

    WAVEWRITER ALPHA 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 7, 2022

    SYNTHES THORACOLUMBAR SPINE LOCKING PLATE (TSLP)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SURE CHECK OVULATION PREDICTOR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    NeuroProbe

    FDA UDI
    ALPHA OMEGA ENGINEERING CO. LTD.·07290014954588·

    NeuroProbe

    FDA UDI
    ALPHA OMEGA ENGINEERING CO. LTD.·07290016450583·

    Sterile neuroprobe

    FDA UDI
    ALPHA OMEGA ENGINEERING CO. LTD.·07290114061988·

    LUX 1440

    FDA Adverse Event
    Malfunction ·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 2, 2013

    SILVERHAWK® PLAQUE EXCISION SYSTEM

    FDA Adverse Event
    Injury ·EV3 INC.·Product code MCW·May 16, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 5, 2008

    WAVEWRITER ALPHA? PRIME

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 6, 2026

    BIPAP AUTOSV ADV

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·March 10, 2022

    Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Probe Kit REF IT2 Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

    BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with expiry 03/2015, intended for the collection of whole blood and the separation of mononuclear cells.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·September 3, 2014

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024