BEUDAMED
    17 results · 21ms · 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 ×

    EchoConfidence (USA)

    FDA 510(k)
    FDA Class 2 ·Radiology

    devemed

    FDA UDI
    devemed GmbH·04061644038213·Bone Spreader | 7.0 mm flat, graduated; 6-8-10-...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197446174·Wagner SWIVEL Rongeur 4mm, s...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197446129·Wagner SWIVEL Rongeur 3mm, s...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197446181·Wagner SWIVEL Rongeur 30 cm,...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197446167·Wagner SWIVEL Rongeur 3mm, s...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197446136·Wagner SWIVEL Rongeur 4mm, s...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197446143·Wagner SWIVEL Rongeur 5mm, s...

    STRATAFIX Spiral PDS Plus Knotless Tissue Control Device

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

    SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 9, 2025

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·September 13, 2011

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FPO·November 14, 2008

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·July 26, 2013

    Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·May 18, 2016

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013