10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
RAREX GREEN FAST
FDA 510(k)
FDA Class 1
·Radiology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150706·K-WIRE - SINGLE TROCAR 1.0mm DIA x 75mm
PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
STAY-PUT IMPREGNATED
FDA 510(k)
FDA Unclassified
·Unknown
AMPLATZER AMULET
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code NGV·May 23, 2024
MACH1 GUIDE CATHETER
FDA Adverse Event
Malfunction
·AVAIL MEDICAL PRODUCTS INCORPORATED·Product code DQY·February 4, 2013
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·December 8, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 17, 2014
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025