BEUDAMED
    17 results · 22ms · 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 ×

    ASA01 HEAVY DUTY SUCTION PUMP

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

    Acapella One

    FDA UDI
    Choice Spine, LP·00840996151313·ACAPELLA,TRIAL,DM,NS,14X16X7

    SPERMCATCH

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CADD

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FRN·July 27, 2020

    UNK - SCREW

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code KWQ·July 26, 2011

    UNK - SCREW

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code KWQ·July 26, 2011

    UNK - SCREW

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code KWA·July 26, 2011

    UNK - SCREW

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code KWQ·July 26, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 22, 2013

    JOURNEY GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQX·April 28, 2011

    CRYSTALENS

    FDA Adverse Event
    Injury ·EYEONICS, INC.·Product code HQL·July 9, 2008

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·March 20, 2013

    HARMONIC ACE 5MM SHEAR

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 3, 2019

    Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·October 7, 2020

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018