BEUDAMED
    21 results · 24ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems

    FDA 510(k)
    FDA Class 2 ·Neurology

    NA

    FDA UDI
    Biedermann Motech GmbH & Co. KG·04250869621243·MOSS VRS Ti rod, Ø5.5x40mm, straight

    NA

    FDA UDI
    Biedermann Motech GmbH & Co. KG·04250869604192·MOSS Ti Rod, Ø5.5x40mm, straight

    InSitu Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127029448·Bipolar Head Assembly, Size 40mm

    Suture Manipulator - Green

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215164843·

    RIVA Posterior Fixation System

    FDA UDI
    XENIX MEDICAL LLC·00840493415642·Closed Lateral Connector, 40mm

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197312752·Beckmann adenoid curette Fig. 4...

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613088484·Blumenthal Rongeur, Angled 30 Degrees, Working ...

    REPROCESSED SURGICAL ELECTRIC INSTRUMENT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    VASCU-GUARD

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code DXZ·April 19, 2023

    COULTER LH 780 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·November 3, 2014

    LIGASURE ATLAS HANDSWITCHING 37CM

    FDA Adverse Event
    Malfunction ·COVIDIEN LLC (SHANGHAI)·Product code GEI·August 12, 2011

    ELLIPSE DR, DF4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2013

    RESTYLANE DEFYNE

    FDA Adverse Event
    Injury ·Q-MED·Product code LMH·June 15, 2023

    iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly, Size 40mm 10-22-0042 Bipolar Head Assembly, Size 42mm 10-22-0044 Bipolar Head Assembly, Size 44mm 10-22-0046 Bipolar Head Assembly, Size 46mm 10-22-0048 Bipolar Head Assembly, Size 48mm 10-22-0050 Bipolar Head Assembly, Size 50mm 10-22-0052 Bipolar Head Assembly, Size 52mm 10-22-0054 Bipolar Head Assembly, Size 54mm 10-22-0056 Bipolar Head Assembly, Size 56mm 10-22-0058 Bipolar Head Assembly, Size 58mm 10-22-0060 Bipolar Head Assembly, Size 60mm

    FDA Enforcement
    Class II ·Ongoing·Theken Companies LLC·October 29, 2025

    ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manufactured by Innominata dba GenBio for Bio-Rad. The kit is used as an aid in diagnosis of Lyme disease.

    FDA Enforcement
    Class II ·Terminated·Innominata Dba Genbio·March 20, 2013

    iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly, Size 40mm 10-22-0042 Bipolar Head Assembly, Size 42mm 10-22-0044 Bipolar Head Assembly, Size 44mm 10-22-0046 Bipolar Head Assembly, Size 46mm 10-22-0048 Bipolar Head Assembly, Size 48mm 10-22-0050 Bipolar Head Assembly, Size 50mm 10-22-0052 Bipolar Head Assembly, Size 52mm 10-22-0054 Bipolar Head Assembly, Size 54mm 10-22-0056 Bipolar Head Assembly, Size 56mm 10-22-0058 Bipolar Head Assembly, Size 58mm 10-22-0060 Bipolar Head Assembly, Size 60mm

    FDA Recall
    Open, Classified ·Theken Companies LLC·Product code MEH·September 11, 2025

    XP-CR Tibial Tray - Interlok 67mm Item # 195271

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

    DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 19, 2023