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

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    HITACHI ALTAIRE

    FDA 510(k)
    FDA Class 2 ·Radiology

    Metal Custom Rx

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746103650·BRACKET MEDIUM TWIN MAX RIGHT CUSPID 018 TQ=-10...

    Battalion

    FDA UDI
    ALPHATEC SPINE, INC.·00840967188966·Battalion, LLIF Trial, 0°, 24 mm Wide, 20 mm X ...

    SLIDESCAN

    FDA 510(k)
    FDA Class 2 ·Hematology

    SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PHILIPS CPAP DEVICE

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·January 7, 2025

    VIBRANT SOUNDBRIDGE

    FDA Adverse Event
    Malfunction ·VIBRANT MED-EL HEARING TECHNOLOGY GMBH·Product code MPV·March 8, 2013

    UNKNOWN DEPUY GLENOID

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWS·February 18, 2011

    ENDOTAK RELIANCE G

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

    VBS SMALL

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code NDN·June 28, 2021

    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

    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