14 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ONCENTRA BRACHY
FDA 510(k)
FDA Class 2
·Radiology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776376338·Stevens Tenotomy Scissors 4 1/2" curved sharp/s...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613024444·Gorney Facelift Scissors, TC, Straight, Overall...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613024451·Gorney Freeman Face Lift Scissors, TC, Straight...
GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
QUANTUM LIGHT THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·May 29, 2013
LENSX LASER SYSTEM
FDA Adverse Event
Injury
·ALCON LENSX LASERS, INC.·Product code OOE·September 29, 2014
PROSTAR XL SUTURE-MEDIATED CLOSURE
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·June 17, 2011
ITREL 3
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 22, 2015
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Alcon Custom Ophthalmic Surgical Procedure Packs
FDA Enforcement
Class II
·Terminated·Alcon Research, LLC·April 7, 2021
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023