BEUDAMED
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    PacBond One

    FDA 510(k)
    FDA Class 2 ·Dental

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319744642·Aufricht (Walter) nasal retractor, double ended...

    WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYNAPSE 3D LIVER ANALYSIS

    FDA 510(k)
    FDA Class 2 ·Radiology

    OT VERIO2 METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 4, 2016

    PLUS SL

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

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 12, 2011

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code MHY·July 8, 2013

    DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 19, 2023

    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

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012