BEUDAMED
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    PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Channels

    FDA UDI
    HENRY SCHEIN, INC.·10304040037802·Channels Hedstrom Files 21mm, #30

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65820201151·Channels Hedstrom Files 21mm

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756001229·Wrist Splint

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717101687·Burs FG 1557, Pkg/100

    In Reach

    FDA UDI
    CURVEBEAM, LLC·00863152000324·Cone Beam Computed Tomography diagnostic extrem...

    PARKS MEDICAL ELECTRONICS, INC.

    FDA registration
    PARKS MEDICAL ELECTRONICS, INC.·7 products·🇺🇸 United States

    90° Infant Osteotomy Plate 25mm/7mm

    FDA UDI
    mahe medical gmbh·EMAH00201152362500·90° Infant Osteotomy Plate 25mm/7mm

    mahe medical GmbH

    FDA UDI
    mahe medical gmbh·04050659185685·90° Infant Osteotomy Plate 25mm/7mm _x000D_...

    Novel

    FDA UDI
    ALPHATEC SPINE, INC.·00811801035494·Bullet-nosed Disc Shavers - 15 mm

    A&D MEDICAL LIFESOURCE UB-401PC & UB-401 DIGITAL BLOOD PRESSURE MONITORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RETIC CHEX LINEARITY

    FDA 510(k)
    FDA Class 2 ·Hematology

    ACCU-CHEK GUIDE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE, INC.·Product code NBW·March 9, 2020

    L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM

    FDA Adverse Event
    Malfunction ·ARGON MEDICAL DEVICES·Product code FOZ·July 31, 2020

    CAPIOX HEMOCONCENTRATOR

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code KDI·March 3, 2016

    Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code LFR·May 25, 2007

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    Malfunction ·CARROLL HEALTHCARE·Product code FNL·March 25, 2013

    CARE ASSIST

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·March 10, 2011

    PULSE GEN MODEL 105

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·March 3, 2015