BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    Prime Adaptive Ultrasonic Scalpel System

    FDA 510(k)
    FDA Unclassified ·Unknown

    Oticon

    FDA UDI
    Oticon A/S·05707131286680·RIA2 PRO, RITE 312 WL TC

    MAKOPLASTY

    FDA UDI
    MAKO SURGICAL CORP.·07613327253535·Acetabular Reamer Basket Case Assembly

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100196·MCINTYRE SPECULUM OPEN WIRE

    Femoral Trial Size 5N

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215073701·

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 2, 2023

    VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KOWA GENESIS-D HAND-HELD RETINAL CAMERA

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    T:SLIM G5 SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OYC·August 17, 2018

    SPECTRANETICS QUICK-CROSS SUPPORT CATHETER

    FDA Adverse Event
    Injury ·THE SPECTRANETICS CORPORATION·Product code DQY·March 6, 2019

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·June 10, 2011

    UNKNOWN EXTERNAL NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·June 6, 2013

    TI 8.5MM POLYAXIAL SCREW ASSY, 40MM (TI-6AL-4V)

    FDA Adverse Event
    Malfunction ·ALPHATEC SPINE INC·Product code KWP·October 14, 2015

    THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty

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