BEUDAMED
    17 results · 29ms · 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 ×

    RANDOX DIGITOXIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040008959·Zirlux 16+ A2 89x17x22

    VENTILATOR TUBING

    FDA UDI
    King Systems Corporation·00612649189246·VENTILATOR CIRCUIT

    S-LIFT®

    FDA UDI
    SPINEFRONTIER, INC.·00190361038351·TRIAL, LORDOTIC, 19MM WIDE, 12MM

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M930701211200·Shaver 12mm

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0120120·Screwdriver, NIDO Assembled Screws, Sleeved

    QUICK SET

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·December 8, 2025

    BIPOLAR COAGULATION SYSTEM

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

    RUBBERCARE POLYMER-CHLORINATED POWDER-FREE GUARDIAN POLYMER-CHLORINATED POWDER-FREE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    QUICK SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 15, 2025

    STYLE 68 SALINE FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FWM·January 8, 2020

    GORE HEMOBAHN ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·March 28, 2013

    AVAULTA SOLO ANTERIOR SYNTHETIC SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BARD SHANNON LIMITED·Product code OTP·March 13, 2013

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FRN·March 4, 2011

    EXTERNAL PADDLES

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 11, 2014

    Pinnacle Destination Guiding Sheath, 6 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lot MD24, MD31, ME07, & ME14. 510(k) K012812 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.

    FDA Recall
    Terminated ·Terumo Medical Corporation·Product code DYB·June 24, 2010

    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