BEUDAMED
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    SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset

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

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319745090·Ferris-Smith Sponge and Fragment Forceps, 4-1/8...

    VEO® Lateral Interbody Fusion System

    FDA UDI
    Choice Spine, LP·00840996133821·LATERAL,60MM CYLINDRICAL

    ACCELEDENT

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFICATION TO TISSUELINK BIPOLAR FORCEPS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

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

    UNKNOWN NEXGEN KNEE

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code JWH·August 10, 2011

    FORTIFY ASSURA VR, DF4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 8, 2013

    ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 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

    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