BEUDAMED
    18 results · 21ms · 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 ×

    Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

    FDA 510(k)
    FDA Class 2 ·Dental

    NA

    FDA UDI
    SYNTHES (U.S.A.) LP·10886982152435·5.0MM LCKNG SCREW SLF-DRLG W/T25 STARDRIVE RECE...

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970492·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970485·

    MEDFUSION 2001 & 2010, MODEL N7215IWC

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS

    FDA 510(k)
    FDA Class 2 ·Dental

    OT VERIO2 METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE GMBH·Product code NBW·March 6, 2019

    OT VERIO SYNC METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 30, 2014

    CELL-DYN 3700 SL ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·August 15, 2011

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 9, 2013

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·August 28, 2023

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·April 25, 2025

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·April 30, 2025

    LOM Disposable Surgical Gowns/Medical Gowns, Single-Use

    FDA Recall
    Open, Classified ·THREAD COUNSEL INC DBA LAWS OF MOTION·Product code FYA·September 17, 2020

    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

    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: Imaging Processing PC, Host PC, FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10 OR Table 722022; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; 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; (Allura Centron - 722400 is impacted by this recall, but Allura Centron systems are not distributed in the United States.)

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024

    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