181 results · 30ms · Sources: EU EUDAMED, US FDA

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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