BEUDAMED
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    COLOSCREEN-ES

    FDA 510(k)
    FDA Class 2 ·Hematology

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092118399·CAMLOG® Screw-Line-compatible 3.8mm X 4.5mm Non...

    Alpha-Tec Systems

    FDA UDI
    Alpha-TEC Systems, Inc.·00816085020655·70% Ethanol

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973530·

    EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150. C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRO

    FDA 510(k)
    FDA Class 2 ·Radiology

    DASH 3000/4000 PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HYBRID OFFSET SHELL INSERTER

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code LXH·May 18, 2016

    LARGE HEXAGONAL SCREWDRIVER

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HXX·February 28, 2013

    COLLEAGUE COLOR PUMP CE FRENCHVERSION SINGLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 1, 2011

    PICC KIT

    FDA Adverse Event
    Injury ·ARROW INT'L INC·Product code LJS·February 4, 2008

    smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    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