BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    NATURAL-KNEE II PATELLOFEMORAL JOINT PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CliP Partial FlexiBAL Titanium

    FDA UDI
    Heinz Kurz GmbH·EHKM10023561·Ossicular Prosthesis, partial

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00723561·

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00273561·

    ONTRAK TESTCUP PRO-5, MODEL 1986678

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    C.T.M. MOBILITY SCOOTER, MODEL H2-686, HS-740, HS-580

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·March 13, 2013

    PINNACLE BANTAM ACET CUP 46MM

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

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Death ·CORDIS DE MEXICO·Product code NIQ·February 22, 2008

    PRESIDIO 10 - CERECYTE MICROCOIL

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code HCG·June 9, 2016

    PRESIDIO 18 - CERECYTE MICROCOIL

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code HCG·June 9, 2016

    Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

    FDA Enforcement
    Class I ·Terminated·Animas Corporation·April 10, 2013

    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