BEUDAMED
    33 results · 32ms · Sources: EU EUDAMED, US FDA

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    FORA G30A BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LAMBERT KAY AORTIC CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896003200·LAMBERT KAY AORTIC DEBAKEY CLAMP DOUBLE CURVED ...

    LAMBERT KAY AORTIC CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09921007320·LAMBERT KAY AORTIC DEBAKEY CLAMP DOUBLE CURVED ...

    TISSUE FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896049598·TISSUE FORCEPS WITH TUNGSTEN CARBIDE PLATFORM I...

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100132611·IN-OVATION® C Roncone 022 U3-3 CS HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100132101·IN-OVATION® C Base Rx 022 U3-3 CS HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100332601·IN-OVATION® C Roncone 022 UL/3-3 CS HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100332101·IN-OVATION® C Base Rx 022 UL/3-3 CS HK

    VITALLINK 1200 MOBILE VITAL SIGNS SYSTEMS (VL 1200 SYSTEM)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LUMINESSE ZR BLANKS

    FDA 510(k)
    FDA Class 2 ·Dental

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code CAW·May 8, 2013

    S4S/SUR-FIT NATURA 2PC-2PC DURAHESIVE (DH) CONVEX MOLDABLE WAFER

    FDA Adverse Event
    Injury ·CONVATEC, INC.·Product code EXE·September 12, 2014

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 12, 2011

    Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018

    Brilliance iCT - Model 728306 Computed Tomography X-ray systems

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·January 31, 2018

    HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·June 12, 2024

    IVEA Product Part Number 16100 Model 500A

    FDA Enforcement
    Class II ·Terminated·Firefly Medical, Inc.·October 11, 2017

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    B125M Patient Monitor, REF 6160000-004-XXXXXX

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·December 28, 2022

    Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021