11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ASAHI ULTIMATEBROS 3 PTCA GUIDE WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNTHES 4.5 MM LCP STRAIGHT RECONSTRUCTION PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
FEMORA, TIBIAL, AND PATELLAR PROSTHESIS
FDA Adverse Event
Malfunction
·HOWMEDICA·Product code KRP·August 31, 1993
PHILIPS CPAP DEVICE
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·March 29, 2024
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 7, 2013
HT50 VENTILATOR
FDA Adverse Event
Injury
·FLIGHT MEDICAL INNOVATION·Product code NOU·July 21, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011
C-QUR MOSAIC
FDA Adverse Event
Injury
·ATRIUM MEDICAL CORPORATION·Product code FTL·October 9, 2015
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012