BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    APC™ PLUS Victory Series™ Low Profile

    FDA UDI
    3M UNITEK CORPORATION·00652221094780·Victory Series(TM) Low Profile Bracket APC(TM) ...

    APC™ Flash-Free Victory Series™ Low Profile

    FDA UDI
    3M UNITEK CORPORATION·00652221232274·Victory Series(TM) Low Profile Bracket APC(TM) ...

    APC™ II Victory Series™ Low Profile

    FDA UDI
    3M UNITEK CORPORATION·00652221063748·Victory Series(TM) Low Profile Bracket APC(TM) ...

    Savant Lumbar Interbody Fusion System

    FDA UDI
    CURITEVA, INC.·B648C26430241260·Titanium ALIF Spacer, 30 x 24 x 12mm, 6 deg

    MODIFICATION TO SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX TV SYSTEM)

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

    SANIDAD HEALTH-UP TENS MP-73725

    FDA 510(k)
    FDA Class 2 ·Neurology

    TI 3-D HEAD FOR TI CLICK X SCREWS

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code MNI·March 27, 2013

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·March 11, 2011

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 5, 2008

    GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DTK·August 31, 2017

    ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG

    FDA Adverse Event
    Injury ·COOK INC·Product code MIH·October 23, 2025

    ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG

    FDA Adverse Event
    Injury ·COOK INC·Product code MIH·October 23, 2025

    PWRD 23MM CURVED CIRCULAR, 18CM SHAFT

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·January 21, 2026

    PWRD 25MM CURVED CIRCULAR, 18CM SHAFT

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·January 21, 2026

    ONETOUCH VERIO FLEX

    FDA Adverse Event
    Malfunction ·UNK·Product code NBW·March 7, 2025

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018