BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    AcuPulse CO2 Laser System, Delivery Devices and Accessories

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Richard-Allan® Needle 1/2 Circle Reverse Cutting

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00840113215348·Intent to be used with suture material for tiss...

    VERIDIAN

    FDA UDI
    VERIDIAN HEALTHCARE LLC·00845717000499·ProKit Aneroid Sphygmomanometer With Dual-Head ...

    SHAKER DIGITAL THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CLEARFIL CORE NEW BOND

    FDA 510(k)
    FDA Class 2 ·Dental

    NA

    FDA Adverse Event
    Malfunction ·ASCENT HEALTHCARE SOLUTIONS·Product code NLQ·October 22, 2008

    PROMUS ELEMENT ¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·August 16, 2011

    GYNECARE TVT RETROPUBIC SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 9, 2013

    HemoCue¿ Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden

    FDA Enforcement
    Class II ·Terminated·HemoCue AB·November 6, 2013

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017

    Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021