16 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Self-Cath and Self-Cath Plus
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD Difco™ QC Antigen Salmonella O Group H
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902214014·Vial Qc Antigen Salmonella O Grp H 1Ml
Luna
FDA UDI
ULTRADENT PRODUCTS, INC.·00883205004420·Luna Opal R Mini .022 Kit 5x5 U & L
Montgomery® VENTRACH™ Speaking Valve
FDA UDI
Boston Medical Products, Inc.·EBES2214011·Size: 15 mm x 22 mm; Color: Green
TriVerse Impactor
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215097561·
Portex
FDA UDI
ICU MEDICAL, INC.·15019517085808·
TENDER TOUCH
FDA 510(k)
FDA Class 2
·Physical Medicine
SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CASPIAN Spinal System
FDA UDI
VB Spine LLC·10888857242593·Mini Manipulator Wrench
TECNIS ITEC PRELOADED 1-PIECE IOL
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQL·November 3, 2014
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·August 24, 2011
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 11, 2013
Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.
FDA Enforcement
Class I
·Terminated·Brainlab AG·January 27, 2016
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 22, 2026
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023