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

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    PENTAX Medical Video Upper GI Scopes EG17-J10

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VERSALOOP™ Straight Guide for 2.5mm Anchor, Fishmouth

    FDA UDI
    T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION·10818674024843·

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319721766·Freeman Flap Retractor 8" (20cm), 12mm wide blade

    TriplePlay

    FDA UDI
    DYMEDIX DIAGNOSTICS, INC.·00817377021978·Interface Cable, NOX-T3, LM1 or LM2

    VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    HELENA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PFNA-II BLADE L80 TAN

    FDA Adverse Event
    Injury ·SYNTHES BETTLACH·Product code HSB·April 24, 2017

    PLUS SL

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

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·July 3, 2013

    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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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