BEUDAMED
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    PARACEM UNIVERSAL DC

    FDA 510(k)
    FDA Class 2 ·Dental

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00530401·

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809845174·FOR MEN 20-30 MM HG KNEE HIGH CLOSED TOE SMALL ...

    Mariner Outrigger

    FDA UDI
    Seaspine Orthopedics Corporation·10889981174057·L Con, Side-Loading, L, 16mm, 40mm

    LIGHT SABER INTRODUCER NEEDLE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    INTRASTENT PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ADVIA CENTAUR CKMB AND TROPONIN ULTRA ASSAY

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JHX·July 29, 2010

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 11, 2013

    INSIGNIA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·April 13, 2011

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code LFR·May 30, 2008

    REF H10

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·August 9, 2016

    TEXIUM CLOSED MALE LUER WITH FEMAILE CAP

    FDA Adverse Event
    Malfunction ·CAREFUSION NORTH CAROLINA·Product code FPA·July 6, 2020

    ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·December 10, 2020

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024