BEUDAMED
    17 results · 29ms · Sources: EU EUDAMED, US FDA

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    CONSENSUS KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Corin BiPolar-i

    FDA UDI
    CORIN LTD·05056139234415·Corin BiPolar-i Ø50/28mm

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694052283·.9mm Twist Drill, 5mm STOP, Hex Shank

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450159033·

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K1103500·Tray, Base, 3.5", Arcamed

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1100500·Caddie, 4.75mm Screws

    VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CYPRESS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    PENTA

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 8, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 8, 2014

    ROBERTAZZI NASAL AIRWAY

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BTQ·May 4, 2011

    UNKNOWN LUMBAR IMPLANT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·April 11, 2022

    ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020

    ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020

    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