Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR

Theraclion

Manufacturer

🇫🇷 France·7 Basic UDI-DIs·8 Devices·BSI Group The Netherlands B.V. and SGS Belgium NV

Morpheus

FDA UDI

PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE·00852423006004·Morpheus® Control Module

663940 Immunochemistry Systems CAL 2 Calibrator 2

FDA registration

BECKMAN COULTER, INC.·7 products·🇺🇸 United States

663940 Immunochemistry Systems CAL 2 Calibrator 2

FDA registration

BECKMAN COULTER, INC.·7 products·🇺🇸 United States

Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion

FDA Pre-Market Approval

FDA Class 3 ·TOP2A FISH PHARMADX KIT

Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion

FDA Pre-Market Approval

FDA Class 3 ·TOP2A FISH PHARMDX KIT

Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion

FDA Pre-Market Approval

FDA Class 3 ·TOP2A FISH PHARMDX

Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion

FDA Pre-Market Approval

FDA Class 3 ·TOP2A FISH PHARMDX KIT

Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion

FDA Pre-Market Approval

FDA Class 3 ·DAKO TOP2A FISH PHARMDX KIT

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·SAFIRE DUO/COOL PATH DUO ABLATION CATHETERS, VERISENSE ENABLED AND VERISENSE SYSTEM AND IBI 1500T9-CP V1.6 CARDIAC

Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)

FDA 510(k)

FDA Class 2 ·Neurology

ASSAYED URINE CONTROL - LEVEL 2 (URN ASY CONTROL 2)

FDA UDI

RANDOX LABORATORIES LIMITED·05055273200539·

ASSAYED URINE CONTROL - LEVEL 3 (URN ASY CONTROL 3)

FDA UDI

RANDOX LABORATORIES LIMITED·05055273200546·

HeRO Graft

FDA registration

MERIT MEDICAL SYSTEMS, INC.·3 products·🇺🇸 United States

HeRO Graft

FDA registration

MERIT MEDICAL SYSTEMS, INC.·3 products·🇺🇸 United States

Merit HeRO Graft

FDA registration

Terumo BCT STERILIZATION SERVICES, Inc.·3 products·🇺🇸 United States