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

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    RICOH MEG

    FDA 510(k)
    FDA Class 2 ·Neurology

    DYONICS POWER HERMES

    FDA UDI
    Smith & Nephew, Inc.·00885556539668·DYONICS PWR HERMES ITALIAN

    VERSALOOP™ 1.5mm Disposable Drill

    FDA UDI
    T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION·10818674024973·

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319706800·Jaeger Lid Plate 4" (10cm), blades 20mm & 23mm

    Dilator, Vascular, acc. DeBakey 19cm 0.5mm

    FDA UDI
    Geister Medizintechnik GmbH·04057034047651·Dilator, Vascular, acc. DeBakey 19cm 0...

    Dilator, Vascular, acc. DeBakey 19cm 0.5mm

    FDA UDI
    Geister Medizintechnik GmbH·04057034047668·Dilator, Vascular, acc. DeBakey 19cm 0...

    BINAXNOW COVID-19 AG SELF TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·September 9, 2022

    DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    PJUR EROS WATER FORMULATION

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PLUS SL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPEDICS AG·Product code KWY·October 23, 2008

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·July 8, 2011

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 8, 2013

    TRUE METRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·April 21, 2023

    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

    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; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    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