BEUDAMED
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    HYGIA HEALTH SERVICE REPROCESSED KENDALL SCD SLEEVE, MODELS # 5329, 5330, 5345, 5480

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450282328·

    Battalion

    FDA UDI
    ALPHATEC SPINE, INC.·00840967187136·Battalion, LLIF Trial, 10°, 24 mm Wide, 17 mm X...

    BRANAN MEDICAL CORPORATION MONITECT METHADONE DRUG SCREEN TEST, MODEL 190C AND 190D

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304

    FDA 510(k)
    FDA Class 2 ·Radiology

    XPS® BUR - STYLUS TRANSNASAL

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·March 16, 2017

    BD CONNECTA¿ STOPCOCK

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·May 15, 2023

    BD CONNECTA¿ STOPCOCK

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·May 15, 2023

    2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM, AO COUPLING

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS-FREIBURG·Product code LXH·March 20, 2013

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 9, 2011

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·March 11, 2008

    ENDOPATH ETS FLEX

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·December 17, 1997

    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

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019