33 results
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11ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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CARESTREAM DRX -Mobile Retrofit Kit, Catalog number: 1019397. 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 Enforcement
Class II
·Terminated·Carestream Health Inc.·November 13, 2013
DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) --- Carestream Health, Inc. The DRX-Revolution Mobile X-Ray System is a mobile imaging system that incorporates a self contained x-ray generator, image receptor, imaging display and software for acquiring medical diagnostic images outside of a standard x-ray room. The DRX-Revolution Mobile X-Ray System has a motor for driving the system so that the operator does not have to push the system, but can walk behind the system while it is moving from one location to another.
FDA Enforcement
Class II
·Terminated·Carestream Health Inc·December 24, 2014
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code: H6-25328
FDA Enforcement
Class II
·Terminated·OMNIlife science Inc.·September 11, 2019
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MOBILITY AID
FDA Enforcement
Class II
·Ongoing·Nova Ortho-Med Inc·October 23, 2024
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H6-25128
FDA Enforcement
Class II
·Terminated·OMNIlife science Inc.·September 11, 2019
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description: ROLLING WALKER MOBILITY AID
FDA Enforcement
Class II
·Ongoing·Nova Ortho-Med Inc·October 23, 2024
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Catalog Number: 4329PL Product Description: ROLLING WALKER MOBILITY AID
FDA Enforcement
Class II
·Ongoing·Nova Ortho-Med Inc·October 23, 2024
ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients.
FDA Enforcement
Class II
·Terminated·Sotera Wireless, Inc.·August 7, 2013
ViSi Mobile Monitor, Catalog No. 92-10010 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients.
FDA Enforcement
Class II
·Terminated·Sotera Wireless, Inc.·August 7, 2013
Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images.
FDA Enforcement
Class II
·Terminated·Carestream Health, Inc.·November 6, 2013
Ziehm Solo. Digital Mobile C-arm
FDA Enforcement
Class II
·Ongoing·Orthoscan, Inc.·December 11, 2024
Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 --- The DRX Revolution Mobile system is a mobile diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are mobile diagnostic x-ray systems 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.·January 15, 2014
GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), REF 71621509, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
FDA Enforcement
Class II
·Terminated·Smith & Nephew Inc·December 11, 2013
Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608
FDA Enforcement
Class II
·Terminated·Carestream Health Inc·February 15, 2017
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
Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR)>
FDA Enforcement
Class II
·Terminated·Fujifilm Medical Systems U.S.A., Inc.·March 27, 2019
Ziehm Vision system, x-ray, tomography, computed.
FDA Enforcement
Class II
·Ongoing·Orthoscan, Inc.·December 11, 2024
Ziehm Vision R. Iterventional fluoroscopic x-ray system
FDA Enforcement
Class II
·Ongoing·Orthoscan, Inc.·December 11, 2024
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