9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
OLYMPUS PF-25 ULTRATHIN ANGIOSCOPE
FDA 510(k)
FDA Class 2
·Cardiovascular
Patterson
FDA UDI
PATTERSON DENTAL SUPPLY, INC.·D6620708715171·FILE, PULP CANAL, ENDODONTIC
AP MEDICAL SHARPS CONTAINERS 0,6-12 LT.
FDA 510(k)
FDA Class 2
·General Hospital
Digital Electrocardiograph
FDA 510(k)
FDA Class 2
·Cardiovascular
PRODISC-C IMPLANT LARGE 5MM-STERILE
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MJO·June 13, 2014
TM SHELL WITH MULTI HOLES
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code KWZ·December 6, 2012
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 26, 2015
SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037
FDA Enforcement
Class II
·Completed·Townsend Design·January 17, 2024
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; 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