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

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    MR8 Drill System, Midas Rex MR8 ClearView Tools

    FDA 510(k)
    FDA Class 2 ·Neurology

    MIDAS REX MR8

    FDA Adverse Event
    Malfunction ·MDT POWERED SURGICAL SOLUTIONS·Product code HBC·May 9, 2025

    MOTOR MR8 ELECTRIC

    FDA Adverse Event
    Malfunction ·MDT POWERED SURGICAL SOLUTIONS·Product code HBB·February 24, 2022

    ZenFlex CM

    FDA UDI
    Kerr Corporation·00195062145537·.25/.04/31mm ZenFlex CM NiTi FILE REFILL PACK

    MICRO TRAY

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896019522·MICRO TRAY DOUBLE LEVEL WITH PIN MAT/RETAINERS ...

    Avalign

    FDA UDI
    Avalign Technologies, Inc.·00190776022938·Microsurgical Case two level

    3DP Lumbar Interbody System

    FDA UDI
    Genesys Orthopedics Systems LLC·M719GL3DS1835150·Small 15-Degree 3DP LLIF - 18mm x 35mm

    3DP Lumbar Interbody System

    FDA UDI
    Genesys Orthopedics Systems LLC·M719GL3DM1835150·Medium 15-Degree 3DP LLIF - 18mm x 35mm

    Apache

    FDA UDI
    Genesys Orthopedics Systems LLC·M719GLLTIM1835150·Medium 15 DEG Titanium LLIF

    Apache

    FDA UDI
    Genesys Orthopedics Systems LLC·M719GLLTIL1835150·Large 15 DEG Titanium LLIF

    Apache

    FDA UDI
    Genesys Orthopedics Systems LLC·M719GLLTIS1835150·Small 15 DEG Titanium LLIF

    INFINION 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 13, 2023

    EQUAL DOSE

    FDA 510(k)
    FDA Class 2 ·Radiology

    HORIZON CARDIOLOGY ECG MANAGEMENT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 18, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 22, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 29, 2011

    T2 STRATOSPHERE

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code MQP·July 1, 2020

    bvi Beaver Xstar Safety Slit Knife: (a) REF 378214, 1.4mm, 45o Bevel Up (b) REF 378215, 1.50mm, 45o Bevel Up (c) REF 378217, 1.7mm, 45o Bevel Up (d) REF 378218, 1.8mm, 45o Bevel Up (e) REF 378220, 2.0mm, 45o Bevel Up (f) REF 378222, 2.2mm, 45o Bevel Up (g) REF 378223, 2.3mm, 45o Bevel Up (h) REF 378224, 2.4mm, 45o Bevel Up (i) REF 378227, 2.75mm, 45o Bevel Up (j) REF 378228, 2.8mm, 45o Bevel Up (k) REF 378230, 3.0mm, 45o Bevel Up (l) REF 378232, 3.2mm, 45o Bevel Up (m) REF 378822, 2.2mm, 45o Double Bevel (n) REF 378824, 2.4mm, 45o Double Bevel (o) REF 378825, 2.5mm, 45o Double Bevel (p) REF 378826, 2.65mm, 45o Double Bevel (q) REF 378827, 2.75mm, 45o Double Bevel (r) REF 378828, 2.8mm, 45o Double Bevel (s) REF 378829, 2.85mm, 45o Double Bevel (t) REF 378830, 3.0mm, 45o Double Bevel (u) REF 378832, 3.2mm, 45o Double Bevel (v) REF 370145, 2.5mm, 45o Bevel Up (w) REF 370146, 2.6mm, 45o Bevel Up (x) REF 373025, kojo, 2.5mm, 45o Bevel Up (y) REF 373032, kojo, 3.2mm, 45o Bevel Up Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

    FDA Enforcement
    Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018