BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    INSPIRA AIR BALLOON DILATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Axiom® MultiPurpose

    FDA UDI
    AXIOM MEDICAL, INCORPORATED·M6651102180·Sump Drain, Two Lumens, Silicone, Splittable

    Aspida

    FDA UDI
    ALPHATEC SPINE, INC.·00190376116013·18mm SACRAL PLATE, TF

    Leva® Anterior Interbody System

    FDA UDI
    Spine Wave, Inc.·10840642117882·Modular Spacer, 34 mm (W) x 28 mm (L ) x 13 mm ...

    Responsive Orthopedics Total Knee Arthroplasty System

    FDA UDI
    RESPONSIVE ORTHOPEDICS, LLC·00841973100409·Poly Insert CR, Size 2, 18mm

    FLOWFLEX COVID-19 ANTIGEN HOME TEST

    FDA Adverse Event
    Malfunction ·ACON LABORATORIES, INC.·Product code QKP·February 9, 2023

    FLOWFLEX COVID-19 ANTIGEN HOME TEST

    FDA Adverse Event
    Malfunction ·ACON LABORATORIES, INC.·Product code QKP·February 8, 2023

    VISTAKON (HEFILCON C) CONTACT LENSES

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM

    FDA 510(k)
    FDA Unclassified ·Unknown

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·December 14, 2018

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 11, 2026

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 13, 2013

    DUAL COOLER/HEATER

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWC·September 10, 2014

    PIC 50

    FDA Adverse Event
    Malfunction ·WELCH ALLYN PROTOCOL, INC.·Product code MKJ·May 20, 2011

    INRATIO PT/INR TEST STRIPS

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC·Product code GJS·July 14, 2017

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016

    EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·July 30, 2014

    Spectral CT. Computed tomography X-ray system.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 2, 2025

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024