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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Cios Alpha

    FDA 510(k)
    FDA Class 2 ·Radiology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517296924·CoRoent® XL-XW, 10x26x55mm

    VULCAN

    FDA UDI
    Smith & Nephew, Inc.·00885556603321·KIT VULCAN GEN ITALY

    MEGA PLUS SPINE SYSTEM

    FDA UDI
    BK MEDITECH CO.,LTD.·08809763501753·Anti-Torque

    NA

    FDA UDI
    Biedermann Motech GmbH & Co. KG·04250869604086·MOSS Ti Rod, Ø5.5x55mm curved

    NA

    FDA UDI
    Biedermann Motech GmbH & Co. KG·04250869610841·MOSS VRS Ti rod, Ø5.5x55mm, curved

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1100550·Caddie, Misc Screws

    REVERSE MEDICAL REFLEX GUIDE CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT EU APPLAUSE CUSTOM

    FDA Adverse Event
    Injury ·ZOLL CIRCULATION, INC.·Product code NCX·August 15, 2025

    SYRINGE 20ML LL S/C 48

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·February 21, 2024

    ULTRACISION HARMONIC SCALPEL LAPAROSONIC BALL COAGULATOR - 5 MM DIAMETER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GEI·October 22, 2008

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·June 27, 2013

    TRIDENT HEMISPHERICAL CLUSTER 58MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code MEH·August 3, 2011

    UNKNOWN MICROCATHETER

    FDA Adverse Event
    Injury ·COVIDIEN (IRVINE)·Product code DQY·May 30, 2017

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·August 8, 2023

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·August 8, 2023

    DigitalDiagnost C50 1.1

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·September 7, 2022

    ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 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

    ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014