BEUDAMED
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    TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Medtronic Reusable Instruments

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00721902097065·CYLN ENDO 16MM BASE CASE

    2440 5 WAY BALLOON VALVE

    FDA UDI
    HANS RUDOLPH, INC.·00874750008667·2440B 5WAY INFLBAL 1.375/1.125

    DIOMED 15 DIODE LASER

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

    RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·June 3, 2013

    AUTOPULSE LI-ION BATTERY

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·May 23, 2013

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·January 20, 2023

    ECHELON*FLEX60 LONG ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60 MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 14, 2013

    COULTER LH 500 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·September 24, 2014

    PROXIMATE*PPH PROCEDURE SET

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 3, 2011

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    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

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025