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

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    MINI VARIABLE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08809265159896·

    Testa™ TP Pivoting Spacer System

    FDA UDI
    Spine Wave, Inc.·10840642176575·Interbody Implant, 27 mm (L) x 14 mm (H) x 7°

    MicroSelectron Digital

    FDA UDI
    Nucletron B.V.·08717213015241·microSelectron Transfer Tube Set for 6F Flexibl...

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08806390860826·

    WATERLASE, MILLENNIUM

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

    DC-7 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·May 14, 2013

    SERVO-I

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·May 20, 2011

    PUMP MMT-522NAS PRDGM INS V2.2 SK EN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·August 12, 2008

    ARTEFILL DERMAL FILLER

    FDA Adverse Event
    Injury ·SUNEVA MEDICAL, INC.·Product code LMH·January 15, 2016

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code MHY·June 6, 2014

    StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.

    FDA Enforcement
    Class II ·Terminated·Abbott Vascular·February 22, 2017

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024