BEUDAMED
    20 results · 20ms · Sources: EU EUDAMED, US FDA

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    SURGICAL DRAPES

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

    Natus

    FDA UDI
    XLTEK·00382830002677·NEUROWORKS 6.3 INTL DVD

    Metal Custom Rx

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746103643·BRACKET NARROW TWIN 018 TQ=0 A=0 R=0 PROFILE=04...

    Battalion

    FDA UDI
    ALPHATEC SPINE, INC.·00840967188959·Battalion, LLIF Trial, 0°, 24 mm Wide, 19 mm X ...

    RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE STYLET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SOLAR SHOULDER OFFSET HUMERAL HEAD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NA

    FDA Adverse Event
    Malfunction ·STERILMED, INC.·Product code NLM·March 8, 2013

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·January 28, 2011

    VENTAK PRIZM HE VR

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code LWS·February 7, 2008

    TefGen is an implant material which is intended to be used as a temporary space-making barrier over bone or other tissue.

    FDA Recall
    Terminated ·Lifecore Biomedical, Inc.·Product code LYC·June 3, 2004

    VERCISE GENUS?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code MHY·February 24, 2026

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 9, 2024

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 9, 2024

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 9, 2024

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 9, 2024

    MEDTRONIC TRANSCATHETER VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·March 15, 2024

    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

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

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

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019