10 results · 17ms · Sources: EU EUDAMED, US FDA

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DEPUY DISPOSABLE FILTER/HOOD

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

Aer-O-Scope Colonoscope System

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

FOCUS VNG/ENG TYPE 1068

FDA 510(k)
FDA Class 2 ·Neurology

INTRALASE FS2

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code HNO·February 14, 2013

TEMPORARY BIPOLAR MYOCARDIAL PACING LEAD

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code LDF·July 28, 2014

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·January 14, 2011

ARCHITECT C16000 SYSTEM

FDA Adverse Event
Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·May 10, 2019

FT3 - FREE TRIIODOTHYRONINE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code CDP·October 10, 2014

FT4, FREE THYROXINE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code CEC·September 30, 2016

Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026