BEUDAMED
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    Evolve Breast Pump

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    KeyPrint

    FDA UDI
    Keystone Industries·H66842004061·KeyDenture Try In, B1, 0.5 KG

    HALSTEAD MOSQUITO FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896084803·HALSTEAD MOSQUITO FORCEPS CURVED TIP

    GUMS SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896083660·GUMS SCISSORS SHARP STRAIGHT BLADE POWER CUT GOLD

    RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FORA V20 BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AXS VECTA 074 CATH 132CM - CE

    FDA Adverse Event
    Injury ·STRYKER NEUROVASCULAR-CALIF·Product code QJP·July 24, 2024

    AMISTEM-P COLLARED

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·October 16, 2025

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 11, 2011

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008

    PRECISION®

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 1, 2013

    CARDIOSAVE HYBRID, TYPE B PLUG

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·January 19, 2024

    Olympus Sterile Optical Laser Fiber, single use and reusable

    FDA Enforcement
    Class II ·Terminated·Quanta System, S.p.A.·June 16, 2021

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021