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

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    SYNGO NEURO PBV-IR

    FDA 510(k)
    FDA Class 2 ·Radiology

    MicroSelectron Digital

    FDA UDI
    Nucletron B.V.·08717213015357·microSelectron Transfer Tube for 5F Flexibles (1)

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1100520·Caddie, 6.5mm Screws

    MYSTIQUE® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K110152101·MYSTIQUE® MB RT RX 022 U 5-5 CS HK

    OMNI III PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Trabecular Metal®

    FDA UDI
    Zimmer, Inc.·00889024129979·

    MAXI MOVE

    FDA Adverse Event
    Malfunction ·ARJO MED AB LTD·Product code FSA·April 19, 2013

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·September 23, 2014

    NEURAGEN NERVE GUIDE 3MM ID X 2CM LENGTH

    FDA Adverse Event
    Other ·INTEGRA, PLAINSBORO·Product code JXI·May 17, 2011

    SURESCAN

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·January 27, 2017

    Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·July 24, 2019

    Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025, UPC 818392014884; 2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1831815B, UPC 818392011593; 3) SOL-M 5ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1851815B, UPC 818392011609; 4) SOL-M 10ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1811815B, UPC 818392011616;

    FDA Enforcement
    Class II ·Ongoing·Sol-Millennium Medical Inc.·September 18, 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