BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    GR-14 Resin System

    FDA 510(k)
    FDA Class 2 ·Dental

    OPIATE ENZYME IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MN-4 COARSE MANIPULATOR

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

    CLEARCORRECT SYSTEM/ALIGNERS

    FDA Adverse Event
    CLEARCORRECT,LLC·Product code NXC·October 17, 2014

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LTI·August 9, 2011

    ENDOTAK DSP

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code LWS·July 8, 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