BEUDAMED
    21 results · 30ms · Sources: EU EUDAMED, US FDA

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    ARAI Surgical Navigation System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Comprehensive® SRS / Discovery®

    FDA UDI
    Biomet Orthopedics, LLC·00880304850347·

    COMPREHENSIVE SRS

    FDA UDI
    Biomet Orthopedics, LLC·00880304540729·

    EAR THERMOMETER, MODELS ST613C AND ST613F

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RELIEVA SOLO ELITE SINUS BALLOON CATHETER

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    PLUM 1.6 PUMP

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code FRN·October 16, 2008

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·August 15, 2011

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 8, 2013

    BEHNING RT NXL ULNA 125MM SEG

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDC·August 30, 2019

    DISC ULNA 3X115MM RT W/BRNG C

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWT·June 20, 2018

    UNKNOWN DISCOVERY HUMERAL CONDYLE KIT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·June 20, 2018

    COMPR SRS LARGE FLANGE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWT·June 20, 2018

    COMPR SRS MOD STEM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·June 20, 2018

    Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstruction

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 4, 2018

    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

    Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132

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

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), 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);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 3, 2026

    Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (722068, 722226, 722236), Azurion 7 M12 (722078, 722223, 722233), Azurion 7 M20 (722079, 722224, 722234, 722282).

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 20, 2026

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025