BEUDAMED
    15 results · 23ms · Sources: EU EUDAMED, US FDA

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    VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Corin BiPolar-i

    FDA UDI
    CORIN LTD·05056139234491·Corin BiPolar-i Ø58/28mm

    Fletcher CT/MR Shielded Applicator

    FDA UDI
    Nucletron B.V.·08717213052659·Clip Part 1

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    UNK FIXATION PIN

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code HSB·October 21, 2019

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    FISTULOK FISTULA NEEDLE PROTECTION

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Neurology

    NEXGEN NKII DURASUL TIBIAL INSERT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·May 9, 2013

    SERVO-I

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·March 18, 2011

    DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM

    FDA Adverse Event
    Injury ·CARDIOVASCULAR SYSTEMS INCORPORATED·Product code MCW·September 23, 2014

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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

    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