BEUDAMED
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    MODIFICATION TO DYNALOK CLASSIC SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SURGIMARK, INC.

    FDA registration
    SURGIMARK, INC.·1 product·🇺🇸 United States

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0134150·Trial, TLIF, 27L OB STR 7Deg, 15mm

    True Position®

    FDA UDI
    ATLAS SPINE, INC.·M68112080234150·34mm x 15mm Non-Lordotic Spacer

    ACCU-CHEK ® GUIDE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE, INC.·Product code NBW·March 15, 2023

    ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYNTHES ANKLE ARTHRODESIS PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CAPD DISCONNECT Y SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·March 27, 2013

    DEPUY ASR XL FEM IMP SIZE 45

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·March 2, 2011

    SELF TAP 4MM WIDERT SCREW INTTHRD 15

    FDA Adverse Event
    Injury ·ABBOTT SPINE, INC.·Product code KWQ·April 2, 2008

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·December 21, 2017

    NEUROWORKS 9.X ACQUISITION SOFTWARE WITH SPIKE / EVENT AND HIGH RES VIDEO

    FDA Adverse Event
    Death ·NATUS MEDICAL INCORPORATED·Product code OMB·February 11, 2024

    DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas

    FDA Enforcement
    Class II ·Terminated·Carestream Health Inc.·November 13, 2013

    DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 Catalog Numbers 1019397, 1023415, 1023423 --- Made in USA by Carestream Health, Inc. 150 The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.

    FDA Enforcement
    Class II ·Terminated·Carestream Health, Inc.·November 6, 2013

    DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients

    FDA Enforcement
    Class II ·Terminated·Carestream Health Inc.·November 13, 2013

    DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients

    FDA Recall
    Terminated ·Carestream Health Inc.·Product code IZL·August 29, 2013

    DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas

    FDA Recall
    Terminated ·Carestream Health Inc.·Product code IZL·June 19, 2013

    DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 Catalog Numbers 1019397, 1023415, 1023423 --- Made in USA by Carestream Health, Inc. 150 The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.

    FDA Recall
    Terminated ·Carestream Health, Inc.·Product code IZL·July 26, 2013

    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

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023