BEUDAMED
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    High Retention Attachment System

    FDA 510(k)
    FDA Class 2 ·Dental

    CD-Chex Plus

    FDA UDI
    STRECK, INC.·00844509000174·A positive procedural control for monitoring im...

    BODYFIX

    FDA 510(k)
    FDA Class 2 ·Radiology

    TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 25, 2014

    ASR UNI FEMORAL IMPL SIZE 39

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    FDA Adverse Event
    Injury ·STAAR SURGICAL CO.·Product code HQL·July 3, 2013

    CA090, DIRECT DRIVE LCA 3/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code FZP·March 10, 2017

    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