15 results · 86ms · Sources: EU EUDAMED, US FDA

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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