BEUDAMED
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    ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814671·GENUMEDI SILVER SIZE IV

    JOBST Bella Strong

    FDA UDI
    BSN MEDICAL, INC.·00035664008994·BELLA STRONG 15-20 MM HG ARMSLEEVE DOT BAND SIZ...

    Lipase Reagent Kit

    FDA UDI
    MEDICA CORPORATION·00386100002237·Lipase Reagent Kit for use with EasyRA Analyzer

    Drive

    FDA UDI
    Drive Devilbiss Healthcare·00822383230955·Walker,2TriggerRel.Junr.w/5"Whls,4/cs

    CRYOPEN CRYOSURGICAL SYSTEM, K102214

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

    SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 30, 2025

    VASO VIEW HEMOPRO

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 8, 2019

    VASOVIEW HEMOPRO 2

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 13, 2019

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FPA·May 9, 2013

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·September 17, 2014

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC.·Product code MND·May 23, 2011

    HEMOPRO 2 ADAPTOR

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR LLC·Product code GEI·February 21, 2020

    GALAXY G3 MINI 2MM X 3CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·August 18, 2020

    Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac as well as interventional Radiology.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 9, 2020

    Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·November 24, 2021

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    ACCOLADE DR EL MRI (Model L331)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025