BEUDAMED
    19 results · 29ms · Sources: EU EUDAMED, US FDA

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    UNICORN MODEL SYS0630

    FDA 510(k)
    FDA Class 2 ·Radiology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040059910·Premium Needle 30Ga X-Short

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040044445·Vaginal Speculum Graves Econ

    GC Fuji ORTHO™

    FDA UDI
    Gc America Inc.·14548161072632·GC Fuji ORTHO™ (2 x 13.3 g (7.2 mL) cartridges ...

    GC Fuji ORTHO™

    FDA UDI
    Gc America Inc.·D0470018881·GC Fuji ORTHO™ (2 x 13.3 g (7.2 mL) cartridges ...

    Dose Drawing Vial Shield, PET 50 ml

    FDA UDI
    Mirion Technologies (capintec), Inc.·00879942070040·Dose Drawing Vial Shield for PET used with Dose...

    SABRATEK TUBING (SABRA SET)

    FDA Adverse Event
    Malfunction ·SABRATEK CORP/BAXTER·Product code FPA·February 12, 2001

    SANSIBAR CPAP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ULTRASIM CT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·Product code KWP·November 2, 2021

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·Product code KWP·November 2, 2021

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·Product code KWP·November 2, 2021

    7700

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 12, 2013

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·February 25, 2011

    CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNUPLASTY RING

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code KRH·February 18, 2008

    OXYSEPT

    FDA Adverse Event
    Injury ·AMO(HANGZHOU) CO., LTD.·Product code LPN·July 8, 2024

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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