BEUDAMED
    24 results · 31ms · Sources: EU EUDAMED, US FDA

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    Disposable Sampler Viral Transport Media

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Comprehensive® SRS

    FDA UDI
    Biomet Orthopedics, LLC·00880304507814·

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551112617·HALO, 1203-5 VEST LARGE, COOLMAX LINER, 1211-1 ...

    TORIC LITE LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ALCO-SCREEN 02

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·November 9, 2022

    COMPR SRS TUMOR BDY - 51MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·March 19, 2026

    THE M-COR MODULAR HIP SYSTEMS

    FDA Adverse Event
    Malfunction ·MIPRO US, INC·Product code LPH·January 23, 2015

    COMP SRS NEXEL 70MM DST BDY LT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWT·May 22, 2026

    COMPR SRS TUMOR BDY - 71MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWT·May 22, 2026

    COMPR SRS IC SEG - 30MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWT·May 22, 2026

    COMPR SRS MOD RGX AUG - LG

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWT·May 22, 2026

    WORKHORSE II PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·ANGIODYNAMICS·Product code DQY·July 12, 2011

    2250051-2008-00350

    FDA Adverse Event
    Malfunction ·Product code KSZ·July 30, 2008

    CONTAK RENEWAL

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 8, 2013

    COMPR SRS TUMOR BDY - 71MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDC·August 15, 2023

    COMPR SRS TUMOR BDY - 71MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDC·August 15, 2023

    COMPREHENSIVE SEGMENTAL REVISION SYSTEM 71MM TUMOR BODY

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWT·May 2, 2017

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system 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.·August 5, 2015

    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