BEUDAMED
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    ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CapSure® Spine System

    FDA UDI
    Spine Wave, Inc.·10840642104721·PS3 Screw 4.5mm x 35mm

    FDI GLUCOSE CONTROL SOLUTION FOR AVIVA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    NORMATEC PCD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CLARIUS ULTRASOUND SCANNER

    FDA Adverse Event
    Malfunction ·CLARIUS MOBILE HEALTH CORP.·Product code IYN·October 17, 2024

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·August 31, 2018

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·February 28, 2014

    ZOOM CRITICAL CARE BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 15, 2013

    TRILOGY SHELL WITH HOLES

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code LPH·May 31, 2011

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·June 27, 2018

    1.55MM X 10MM FLUTED TWIST DRL

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 17, 2016

    1.55MM X 10MM FLUTED TWIST DRL

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 17, 2016

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    FDA Enforcement
    Class II ·Ongoing·Abbott Medical·January 1, 2025