15 results
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86ms
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Sources: EU EUDAMED, US FDA
P and G Engineering, Incorporated
Manufacturer
🇺🇸 United States·1 Importer
P AND G ENGINEERING, INCORPORATED
FDA registration
P AND G ENGINEERING, INCORPORATED·1 product·🇺🇸 United States
Astral Healthcare
Authorized representative
🇮🇪 Ireland·1 Manufacturer
ERGO IMAGING SYSTEM
FDA Adverse Event
Malfunction
·DIGIRAD DIAGNOSTIC IMAGING (DBA CATALYST MEDTECH)·Product code KPS·December 5, 2025
Stryker EMEA Supply Chain Services BV
Importer
🇳🇱 Netherlands·48 Manufacturers
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
REVOLUTION CT
FDA Adverse Event
Injury
·GE MEDICAL SYSTEMS, LLC·Product code JAK·May 6, 2019
UNISYN HIP SYSTEM
FDA Adverse Event
Malfunction
·CONSENSUS ORTHOPEDICS INC·Product code JDI·July 31, 2014
GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code NIP·June 24, 2025
EC-5000 QUEST
FDA Adverse Event
Malfunction
·NIDEK INC.·Product code LZS·November 9, 2017
YC-1800
FDA Adverse Event
Malfunction
·NIDEK CO., LTD·Product code LXS·April 27, 2018
GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·W.L. GORE & ASSOCIATES·Product code NIO·May 25, 2020
EQUINOXE RS GLENOID PLATE EXT CAG +10MM CAGE PEG
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·November 11, 2025
EQINOXE REVERSE COMPRESSION SCREW
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·November 11, 2025
EQINOXE REVERSE COMPRESSION SCREW
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·November 11, 2025