BEUDAMED
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    MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091032706·Baltic Denture System BDLoad Mn7 PLSEbim6DFm BL...

    Cook

    FDA UDI
    COOK INCORPORATED·00827002170766·Silicone Universal Drainage Stent

    IM2001 PULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI

    FDA 510(k)
    FDA Class 2 ·Hematology

    AMBIENT SUPER MULTIVAC 50 IFS

    FDA Adverse Event
    Malfunction ·ARTHROCARE CORP.·Product code GEI·March 9, 2020

    NELLCOR N20PA

    FDA Adverse Event
    Malfunction ·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code DQA·March 29, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·March 29, 2011

    ACCU-CHEK AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 22, 2008

    BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·April 17, 2018

    Vitros Immunodiagnostic HBsAg CONFIRMATORY KIT * REF 680 1324. Firm on label: Ortho-Clinical Diagnostics, 62 The Broadway, Amersham, Bucks, UK. UPC *+H221680132412* . Each kit contains: 1 x kit of reagents, and protocol card for HBsAg Confirmatory Kit. According to the firm (but not on label), there are 60 neutralization reactions per confirmatory kit.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code LOM·December 15, 2005

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024