BEUDAMED
    19 results · 21ms · Sources: EU EUDAMED, US FDA

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    RIGID GAS PERMEABLE CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Duesseldorf Type Bell Partial

    FDA UDI
    Heinz Kurz GmbH·EHKM10020251·Ossicular prosthesis, partial

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092002025·artVeneer life lower posteriors, M, A3

    Silverbolt/Mainframe

    FDA UDI
    Choice Spine, LP·00840996170765·SILVERBOLT,SCREW,POLYAXIAL,5.5X25

    AlphaGRAFT

    FDA UDI
    ALPHATEC SPINE, INC.·00844856026728·AlphaGRAFT, Bone Matrix Putty, Demineralized, 2...

    CorticaLINK

    FDA UDI
    LINKSPINE, INC.·00817329020011·5.0mm CoCr Rod: 25mm Straight

    LIFECARD CF COMPACT RECORDER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARD GUARD PERSONAL ELECTROCARDIOGRAM TRANSMITTER, MODEL CG-6206/6306

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SALINE TEXTURED BREAST IMPLANT

    FDA Adverse Event
    MCGHAN MEDICAL CORP.·Product code FWM·May 17, 1994

    UNKNOWN VLOC PRODUCT

    FDA Adverse Event
    Injury ·COVIDIEN SURGICAL·Product code GAM·November 7, 2025

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVN·March 13, 2013

    PUMP/GRAVITY SOLUTION NO 'Y' SITE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code FPA·February 27, 2011

    LAMINARIA TENT

    FDA Adverse Event
    Injury ·Product code HDY·February 20, 2008

    UNKNOWN SOLITAIRE

    FDA Adverse Event
    Death ·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·April 7, 2026

    MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 00850024195141 MP2015A - MOLLI OncoPen UDI (GTIN): 00850024195219 MT2001 - MOLLI 2 Tablet UDI (GTIN): 00850024195158 The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the MOLLI Marker is located and surgically removed with the target tissue.

    FDA Enforcement
    Class II ·Ongoing·Stryker Corporation·February 25, 2026

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    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