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

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    Infrared Thermometer

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NA

    FDA UDI
    Smith & Nephew, Inc.·23596010513773·LATERAL SUPPORT KNOBS

    PEEK PREVAIL™ Cervical Interbody Device

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994502087·IMPLANT 4210564 STANDALONE 16 X 14 X 5MM

    TO BE ASSIGNED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033540046·

    SMARTLOCK

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613153173632·LOCKING PLATE,SAGIT. SPLIT,STR.,6MM BAR

    VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO; PROFILE -II 7 THC/COC/OPI/AMP/PCP/BAR/BZO

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CALYPSO SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PFC SIGMARP STB TB IN 3 10.0

    FDA Adverse Event
    Injury ·DEPUY-CORK, A DIVIISON OF DEPUY ORTHOPAEDICS·Product code NJL·October 22, 2008

    7 MM EXTENDED LENGTH ENDOSCOPE

    FDA Adverse Event
    Malfunction ·MAQUWT CARDIOVASCULAR, LLC·Product code GCJ·August 8, 2011

    UNIFY ASSURA CRT-D

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 8, 2013

    BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QKP·October 29, 2020

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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 Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    Model Number L211 PROPONENT DR SL MRI Pacemaker

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

    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

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025