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

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    RetinAI Discovery

    FDA 510(k)
    FDA Class 2 ·Radiology

    SIJ Plate

    FDA UDI
    I.T.S. GmbH·09120034302954·SIJ Plate, 5-Hole, Right

    MACROPORE IB RESORBABLE PLUG

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EMBRYOSCOPE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PUMP MMT-722NAS PRDGM INS V2.2 SK EN

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·October 23, 2008

    PFC CVD 8MM SZ4

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·August 10, 2011

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD·Product code MCM·July 8, 2013

    BD VERITOR¿ SARS-COV-2 AND FLU A+B

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QMN·October 6, 2021

    Deltec Cozmo Insulin Pump, model 21-1700. A syringe infusion pump designed for Continuous Subcutaneous Insulin Infusion for the control of diabetes. Reorder Numbers: 21-1701-02/32/33/36/44/49/51/54/62/63/66/81 21-1702-02//49/51 21-1703-02/32/33/36/44/49/51/54/62/63/66/81 21-1704-02/32/33/36/44/49/51/54/62/63/66/81 21-1705-79 21-1706-79 21-1707-79 21-1711-01/02/03/06/14/50 21-1712-01/02 21-1713-01/02/03/06/14/50 21-1714-01/02/03/06/14/50 21-1715-19 21-1716-19 21-1717-19

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code LZG·February 22, 2008

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021