17 results
·
28ms
·
Sources: EU EUDAMED, US FDA
HELIX HYDRO-JET
FDA 510(k)
FDA Class 2
·General Hospital
Safco economy saliva ejectors
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310226133·Safco economy saliva ejector clear
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690129943·PS-C Insert, Size 6 x 13mm
Spine Innovation Interbody System
FDA UDI
SPINE INNOVATION, LLC·00817722020199·Expandable Implant 0° x 12mm W x 13mm H x 26mm L
MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
REPROCSSED LINVATEC SHAVERS
FDA 510(k)
FDA Class 2
·Orthopedic
IMMULITE 2000
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CFP·January 23, 2012
IMMULITE 2000
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CFP·February 2, 2012
COOK CELECT FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Other
·WILLIAM COOK EUROPE·Product code DTK·March 22, 2013
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·March 17, 2011
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·March 31, 2008
IMMULITE 2000 INSULIN
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code CFP·January 27, 2012
IMMULITE 2000 INSULIN
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code CFP·February 1, 2012
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025