BEUDAMED
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    Indigo Aspiration System Lightning Aspiration Tubing

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    N/A

    FDA UDI
    STRYKER SUSTAINABILITY SOLUTIONS, INC.·00885825003678·Steerable Diagnostic EP Catheter , LARGE 4.0, 6...

    STRABISMUS BABY SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896055636·STRABISMUS BABY SCISSORS STRAIGHT BLADE POWER C...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694045056·SmartFlex Inserter

    ACON ONE STEP DRUG SCREEN TEST CARD

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DIMAX 2

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 29, 2025

    ECHELON LINEAR CUTTER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 24, 2014

    SIGN FIN NAIL

    FDA Adverse Event
    Injury ·SURGICAL IMPLANT GENERATION NETWORK (SIGN)·Product code HSB·July 28, 2011

    CUB PEDIATRIC CRIB- FIXED BASE

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FMS·July 1, 2013

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016