BEUDAMED
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    UCR SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091032739·Baltic Denture System BDLoad ↓ Ln6 PLSEum4DFl B...

    INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CONVERGE ACETABULAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code JSG·May 29, 2024

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·February 14, 2012

    FLEXI-SEAL FMS

    FDA Adverse Event
    Other ·CONVATEC·Product code KNT·June 7, 2006

    DUROM US ACETABULAR COMPONENT 56/50 P

    FDA Adverse Event
    Other ·ZIMMER GMBH·Product code KWA·March 8, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 25, 2014

    BRAVO PH CAPSULE WITH DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·GIVEN·Product code FFT·February 21, 2011

    FLEXI-SEAL FECAL MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·CONVATEC INC.·Product code KNT·October 20, 2016

    BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code JSG·May 2, 2024

    i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac I troponin measurement cane be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.

    FDA Enforcement
    Class II ·Terminated·Abbott Point Of Care Inc.·August 29, 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

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016