BEUDAMED
    10 results · 20ms · 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.

    LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092104255·Biomet 3i Certain®-compatible 4.1mm Esthetic Ab...

    XIA SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POLYESTER NONABSORBABLE SURGICAL SUTURES URP

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

    ARCHITECT TOTAL B-HCG

    FDA Adverse Event
    Malfunction ·A.I.D.D LONGFORD·Product code DHA·March 13, 2013

    SECURE II MED/SURG MED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·February 3, 2011

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·February 19, 2008

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

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

    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

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016