BEUDAMED
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    DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ROSE K POST GRAFT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SUTUREGROOVE WEIGHT SIZING SET

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ROUND FILTER POLYPROVPYLENE

    FDA Adverse Event
    Malfunction ·SPS MEDICAL SUPPLY CORP·Product code FRG·June 25, 2013

    CORAIL2 STD SIZE 10

    FDA Adverse Event
    Injury ·DEPUY FRANCE SAS 3003895575·Product code MEH·May 6, 2013

    EON

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 4, 2014

    PFC SIGMARP CV TB/IN S4 10.0

    FDA Adverse Event
    Injury ·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code NJL·May 12, 2011

    INNOVANCE D-DIMER

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code DAP·July 14, 2017

    THORATEC® HEARTMATE II®, SYSTEM CONTROLLER

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·June 11, 2024

    Hitachi HIVISION Preirus/Avius Ultrasound equipped with V03.02 Software - Doppler Trace Measurement program. 510 (k) Numbers: Preirus - K093466 (6/1/10), Avius - K102901 (10/27/10). The Preirus and Avius are intended for use by trained personnel (doctors, sonographers, etc) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Feta, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Genecology, Urology and Laparoscopic clinic applications. The Modes of Operation of the HIVISION Preirus are B mode, M mode PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler) Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, RealTime Tissue Elastography, and Real Time Virtual Sonography.

    FDA Recall
    Terminated ·Hitachi Medical Systems America Inc·Product code IYN·April 18, 2011

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015