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

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    ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MicroSelectron Digital

    FDA UDI
    Nucletron B.V.·08717213015227·microSelectron Transfer Tube for 6F Flexibles (8)

    Testa™ TP Pivoting Spacer System

    FDA UDI
    Spine Wave, Inc.·10840642176551·Interbody Implant, 27 mm (L) x 12 mm (H) x 7°

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08809265159599·

    SHIMADZU COLLIMATOR R-300

    FDA 510(k)
    FDA Class 2 ·Radiology

    OMNILINK .018 BILIARY STENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·January 20, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·January 20, 2022

    BELLAFILL DERMAL FILLER

    FDA Adverse Event
    Injury ·SUNEVA MEDICAL, INC.·Product code LMH·November 22, 2023

    SERVO-S

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·April 17, 2013

    GMK FEMORAL CUTTING GUIDE

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·May 5, 2011

    PUMP MMT-715LNAS PRDGM INS V2.1 SK EN

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·August 12, 2008

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·May 4, 2022

    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

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021