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

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    GORE ACUSEAL VASCULAR GRAFT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814787·GENUMEDI EXTRA WIDE SILVER SIZE V

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694091473·1.6mm Modified LeFort Plate, Right, 0mm

    N/A

    FDA UDI
    Tyber Medical, LLC·M695M1302150·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450189924·

    BIORAPID MONONUCLEOSIS

    FDA 510(k)
    FDA Class 2 ·Immunology

    ARCHIMED REMEDY CERVICAL PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SET, ADMINISTRATION, INTRAVASCULAR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·June 6, 2016

    Truliant

    FDA UDI
    Exactech, Inc.·10885862314628·

    AVALON ELITE

    FDA Adverse Event
    Injury ·AVALON LABORATORIES LLC·Product code DWF·August 26, 2010

    STOPCOCK MANIFOLD GANGS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FMG·June 17, 2020

    COBLATOR II

    FDA Adverse Event
    Malfunction ·ARTHROCARE CORPORATION·Product code GEI·May 22, 2013

    7.5CM ANGLE ATTACHMENT

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·September 30, 2014

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·June 16, 2011

    55MM SELECTABLE NEW TLC

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 17, 2019

    Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4" X 4 ", 6 mm X100 mm, (2 Cards/pouch, 1,000 Pouches/box); Distributed in Europe: " Product Number: 39-0058: Medicare Reinforced Wound Closure Strips 1/4" X 4 ", Sterile, Box 1000 pouches 5 strips /pouch, Pouch , 5 strips 6 mm X100 mm Sterile EO Product Number: 40-2893: Wound Closure Strips , Sterile (1,000pouches/box) Rx; Pouch Label: Wound Closure Strips 6 mm X100 mm, 1/4" X 4 ", Rx Product Usage: intended for skin closure and closure support for sutures and staples

    FDA Enforcement
    Class II ·Terminated·Aspen Surgical Products, Inc.·August 28, 2013

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015