181 results
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30ms
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Sources: EU EUDAMED, US FDA
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·HYDRON(R) (POLYMACON) HYDROPHILIC CONTACT LENSES
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·\YDRON(R) (POLYMACON) HYDROPHILIC CONTACT LENSES
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756966924·DOUBLE BASIN SET
15° Esthetic Abutment H1mm Ti
FDA UDI
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION·10810190011024·
Standard Healing Cap 2mm
FDA UDI
NOGA MEDICAL PRODUCTS LTD·07290118142980·Standard Healing Cap 2mm
PATIENT CARE MANAGEMENT SYSTEM MODIFICATION
FDA 510(k)
FDA Class 2
·Cardiovascular
FORTIFY ASSURA DR ICD, US
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)·Product code LWS·June 13, 2016
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·EUFLEXXA (1% SODIUM HYALURONATE)
FORTIFY ASSURA VR ICD_IDE_US
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)·Product code LWS·March 29, 2017
ELLIPSE VR ICD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)·Product code LWS·March 29, 2017
ALINITY I HBSAG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·March 16, 2026
CD2257-40Q FORTIFY ASSURA DR ICD_IDE_US
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)·Product code NVZ·June 14, 2017
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·January 11, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 10, 2010
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 2, 2014
ARCHITECT HBSAG QUALITATIVE II
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·March 31, 2026
ALINITY I HBSAG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·May 18, 2026
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·Euflexxa (1% Sodium Hyaluronate)
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Alinity i HBsAg Qualitative II Reagent Kit (2x100 Tests), Alinity i HBsAg Qualitative II Reagent Kit (2x600 Tests), Alin