16 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MEGA 5.5 SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
JET DENTURE REPAIR
FDA UDI
LANG DENTAL MANUFACTURING CO., INC.·D6501234760·FAST CURING DENTURE REPAIR ACRYLIC RESIN POWDER...
BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX
FDA 510(k)
FDA Class 2
·Radiology
UNIPACS WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
TRIATHLON P/A CR BEADED #5L
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MBH·January 29, 2024
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·May 22, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 26, 2014
CAPSURE SP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 14, 2011
TRIATHION
FDA Adverse Event
Injury
·HOWMEDICA OSTEONICS CORP.·Product code JWH·December 14, 2023
TRIATHION COMPONENT
FDA Adverse Event
Injury
·HOWMEDICA OSTEONICS CORP.·Product code JWH·December 14, 2023
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·December 22, 2020
1.55MM X 10MM FLUTED TWIST DRL
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 17, 2016
1.55MM X 10MM FLUTED TWIST DRL
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 17, 2016
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023
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