BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    SYNTHES 90 DEGREE SCREWDRIVER

    FDA 510(k)
    FDA Class 2 ·Dental

    1.5MM DIA DRILL BIT W/6MM STOP 13MM LENGTH F/90° SCREWDRIVER

    FDA Adverse Event
    Injury ·SYNTHES SELZACH·Product code DZI·May 19, 2015

    OCTAGON Infinity TL RP Abutment angled 15° B H= 5.7 mm cementable

    FDA UDI
    Hager & Meisinger Gesellschaft mit beschränkter Haftung·XXXX50826499·TL RP Abutment angled 15° B H= 5.7 mm cementabl...

    OCTAGON Infinity TL RP Abutment angled 15° B H= 5.7 mm cementable

    FDA UDI
    Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM50826491·TL RP Abutment angled 15° B H= 5.7 mm cementabl...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450182178·

    ARAMIS DERMATOLOGICAL LASER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    RAICHEM BUN RATE REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    IMPL TAPERED SP 3.7MM 12M M OCTAGON

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·July 10, 2024

    IMPL TAPERED SP 3.7MM 12M M OCTAGON

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·June 12, 2024

    IMPL TAPERED SP 4.8MM 8MM OCTAGON

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·July 10, 2024

    ACCU-CHEK ® SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE AG·Product code LZG·April 29, 2013

    VISX EXCIMER LASER

    FDA Adverse Event
    Injury ·AMO MANUFACTURING USA, LLC·Product code LZS·April 27, 2011

    JAGWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code EZB·July 23, 2008

    IMPL TAPERED SP 3.7MM 10M M OCTAGON

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·July 27, 2023

    IMPL TAPERED SP 4.8MM 8MM OCTAGON

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·March 3, 2023

    COOK-SWARTZ DOPPLER PROBE

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code ITX·September 6, 2015

    Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·November 30, 2016

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    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