10,000 results · 27ms · Sources: EU EUDAMED, US FDA

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS ONE-PIECE SOFT ACRYLIC INTRAOCULAR (IOL) MODEL ZCB00 & TECNIS MULTIFOCAL ONE-PIECE IOL MODEL ZMB00

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval
FDA Class 3 ·Optune® device

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·JJSV's One-Piece IOL's with Daisy-Whell packaging configuration, JJSV's One-Piece IOLs with TECNIS SmartLOAD Delivery Te

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·enVista One Piece Hydrophobic Acrylic Intraocular Lens

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Akreos One-Piece Acrylic Intraocular Lens (IOL)

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·MOBI-C CERVICAL DISC PROSTHESIS (ONE LEVEL)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Akreos One-Piece Foldable Acrylic Intraocular Lens

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ONE PIECE CM (R) POS.CHAMBER INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS MULTIFOCAL ONE-PIECE INTRAOCULAR LENS (IOL)

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·Mobi-C Cervical Disc Prosthesis One-level

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·NanoFLEX One Piece Collamer Intraocular Lens (CIOL)

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·Mobi-C Cervical Disc Prosthesis One Level

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·enVista One-Piece Foldable Acrylic Intraocular Lens