BEUDAMED
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    AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SimplyGo Mini

    FDA UDI
    Respironics, Inc.·00606959032408·SimplyGo Mini with Extended Battery, USA

    N/A

    FDA UDI
    HANS RUDOLPH, INC.·00874750003884·75 V2 SM 22OD STRAIGHT NO HG

    EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) W/ A PROTEIN CONTENT LABEL CLAIM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    HNC-63-INT NEUROVASCULAR ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    SPACELABS ULTRAVIEW SL COMMAND MODULE

    FDA Adverse Event
    Malfunction ·SPACELABS HEALTHCARE INC.·Product code DSI·April 21, 2015

    SPACELABS ULTRAVIEW SL COMMAND MODULE

    FDA Adverse Event
    Malfunction ·SPACELABS HEALTHCARE INC.·Product code DSI·April 21, 2015

    SPACELABS ULTRAVIEW SL COMMAND MODULE

    FDA Adverse Event
    Malfunction ·SPACELABS HEALTHCARE INC.·Product code DSI·April 21, 2015

    SPACELABS ULTRAVIEW SL COMMAND MODULE

    FDA Adverse Event
    Malfunction ·SPACELABS HEALTHCARE INC.·Product code DSI·April 21, 2015

    CORMET RESURFACING

    FDA Adverse Event
    CORIN, LTD.·Product code NXT·May 10, 2013

    NAIL, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code JDS·September 24, 2014

    HEARTSTART MRX - EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL·Product code MKJ·May 24, 2011

    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 Recall
    Terminated ·Spacelabs Healthcare Inc·Product code DSI·April 21, 2015

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    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

    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