BEUDAMED
    14 results · 22ms · 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 ×

    Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Bernafon

    FDA UDI
    Bernafon AG·05711584114551·CO3 B 105, 2.4G NFM MSIL CAPTO 3 GPL

    VARIAX

    FDA UDI
    Stryker GmbH·04546540540898·Hand Screwdriver Handle, 1.2

    Unity

    FDA UDI
    DIOMEDICAL CO.,LTD.·08800039821674·SIJ Lag ScrewOD12.5xL55

    CD HORIZON(R) SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    FDA Adverse Event
    Injury ·GENZYME BIOSURGERY (SEPRAFILM/PACK)·Product code MCN·October 27, 2008

    NEUROMONITOR BASIC KIT

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC., MEDOS S.A.·Product code GWM·August 11, 2011

    INCEPTA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013

    BD SYRINGE LUER-LOK¿ TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 6, 2017

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·June 25, 2025

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·March 3, 2025

    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 AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 22, 2026