BEUDAMED
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    IN VISION GOLD WITH SPIN VISION, MODEL 891 SV

    FDA 510(k)
    FDA Class 2 ·Radiology

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809848335·FOR MEN 15-20 MM HG KNEE HIGH CLOSED TOE LARGE-...

    Oph.Forceps

    FDA UDI
    KATENA PRODUCTS, INC.·00841668116289·Nichamin II Lens Insert Fcps, Titanium

    MASTISOL

    FDA UDI
    FERNDALE LABORATORIES, INC.·00304960523488·LIQUID ADHESIVE

    SHOULDER ARTHROSCOPY (SAOOA)647

    FDA Adverse Event
    Other ·CARDINAL HEALTH·Product code HRX·May 31, 2007

    ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-2000

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MAXIM RPG PS FEMORAL COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 5, 2025

    PENTA

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 4, 2013

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 6, 2008

    MINICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·April 12, 2011

    Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description: Liquid adhesive, 2/3 mL vial, 48 vials per carton Component: No

    FDA Recall
    Open, Classified ·Ferndale Laboratories, Inc.·Product code KGX·November 25, 2025

    MASTISOL LIQUID ADHESIVE

    FDA Adverse Event
    Other ·FERNDALE LABORATORIES, INC.·Product code KGX·August 11, 2011

    Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description: Liquid adhesive, 2/3 mL vial, 48 vials per carton Component: No

    FDA Enforcement
    Class II ·Ongoing·Ferndale Laboratories, Inc.·January 7, 2026

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014