BEUDAMED
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    SANSIN Tubing Sets for Hemodialysis

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

    MODIFICATION TO PROVIDENT HIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CERCON CERAM S PORCELAIN

    FDA 510(k)
    FDA Class 2 ·Dental

    INTELLAMAP ORION?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·May 12, 2026

    INTELLAMAP ORION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 15, 2025

    INTELLAMAP ORION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 29, 2026

    INTELLAMAP ORION?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 17, 2026

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code KDI·October 15, 2008

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code DHA·August 11, 2011

    UV FLASH TRANSFER SETS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 2, 2013

    INTELLAMAP ORION?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·January 30, 2026

    INTELLAMAP ORION?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 1, 2026

    INTELLAMAP ORION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·November 21, 2024

    INTELLAMAP ORION?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·February 26, 2026

    INTELLAMAP ORION

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·December 12, 2024

    CARDINAL HEALTH RAPID TEST HCG COMBO 30T

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO·Product code JHI·September 26, 2019

    Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    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

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025