BEUDAMED
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    FRESH, DENTAL IMPRESSION MATERIAL

    FDA 510(k)
    FDA Class 2 ·Dental

    Premier H-FILES

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·D6919053427·FILES HEDSTROM PKG 6 25MM 20

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809842197·FOR MEN 30-40 MM HG KNEE HIGH OPEN TOE MEDIUM-L...

    MODIFICATION TO:PHILIPS M3000A/M3046A COMPACT PORTABLE PATIENT MONITOR, MODELS PHILIPS M3000A/M3046A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ZINC PHOSPHATE CEMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    BD INSULIN SYRINGES WITH THE BD ULTRA FINENEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·October 26, 2021

    RAD-57 PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·July 26, 2023

    BD INSULIN SYRINGES WITH THE BD ULTRA FINENEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·October 26, 2021

    1.0MM TI CRTX SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 5MM

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code HRS·April 11, 2013

    VIASYS

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code CBK·March 17, 2011

    PRECISE OTW NITINOL STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIM·May 27, 2008

    BD SYRINGE 0.5ML 31GA 6MM

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·August 3, 2021

    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

    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