BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

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    NEUMOVENT GRAPHNET MODEL 3179L1V

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489105619·PowerChem Neoprene Exam Gloves, Extra Small

    Bur PM2-70 80K diam Ø1.5x80 St

    FDA UDI
    Bien-Air Surgery SA·17630055519563·

    eTRAX™ Needle System Starter Kit

    FDA UDI
    CIVCO MEDICAL INSTRUMENTS CO., INC.·00841436103206·Reusable non-sterile needle sensor with sterile...

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383555999·Gutta Percha Points is used to root canal filin...

    Innomed, Inc.

    FDA UDI
    INNOMED, INC.·00840277115751·Modified Kolbel Self Retaining Glenoid Retracto...

    Innomed, Inc.

    FDA UDI
    INNOMED, INC.·00840277120885·Kolbel Glenoid Retractor with Hinge Ergonomic H...

    AMT THERAPEUTIC TABLE, MODEL 748AMT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    RAMBLER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·January 25, 2022

    R SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 29, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 19, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·May 24, 2011

    Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781315

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021

    STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

    FDA Recall
    Terminated ·Steris Corporation Hopkins Facility·Product code MED·December 7, 2011

    Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 102115SN, UPC 818392019858; 2) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 102215SN, UPC 818392019865; 3) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*1 (needle aside), Model No. 12510SN, UPC 818392018851; 4) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8 (needle aside), Model No. 12558SN, UPC 818392018950; 5) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 27G*1/2 (needle aside), Model No. 12705SN, UPC 818392018967; 6) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 30G*1/2 (needle aside), Model No. 13005SN, UPC 818392018974; 7) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G*1 (needle aside), Model No. 32110SN, UPC 818392019001; 8) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 32115SN, UPC 818392019018; 9) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 22G*1 (needle aside), Model No. 32210SN, UPC 818392019025; 10) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 32215SN, UPC 818392019032; 11) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 23G*1 (needle aside), Model No. 32310SN, UPC 818392019049; 12) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*1 (needle aside), Model No. 32510SN, UPC 818392019063; 13) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*5/8 (needle aside), Model

    FDA Enforcement
    Class II ·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025