BEUDAMED
    2 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers. 1. I.T.S. DUL (Distal Ulna Locking) System, Distal Ulna Plate; Article Numbers: 21232-3, 21232-4, 21232-6, 21233-3, 21233-4, 21233-6, 21234-4, 21235-4. 2. I.T.S. UOL (Ulna Osteotomy Locking) System, Ulna Osteotomy Plate; Article Numbers: 21231-6. 3. UOL (Ulna Osteotomy Locking) System, Cancellous Screw, Locking; Article Numbers: 37302-18, 37302-20.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    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