47 results · 19ms · Sources: EU EUDAMED, US FDA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·ACCESS HYBRITECH PSA ON THE SYNCHRON LXI 725 SYSTEM

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·ACCESS HYBRITECH PSA REAGENTS ACCESS IMMUNOASSAY SYSTEMS

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·Dimension TPSA Flex reagent cartridge (RF451)

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·OPUS(R) CEA TEST SYSTEM

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·CLARIS(TM) REWETTING DROPS

Medication Management System, Remote

FDA classification
FDA Class 2 ·Medication Management System, Remote

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval
FDA Class 2 ·BAK INTERBODY FUSION SYSTEM, BP/LORDOTIC DEVICE

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval
FDA Class 2 ·BAK VISTA INTERBODY FUSION DEVICE

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval
FDA Class 2 ·BAK VISTA INTERBODY FUSION CAGE

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval
FDA Class 2 ·BAK VISTA INTERBODY FUSION CAGE

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·CUTTING BALLOON ULTRA

Cannula, Injector, Uterine, Endometrial Biopsy

FDA classification
FDA Class 2 ·Cannula, Injector, Uterine, Endometrial Biopsy

Intracardiac Patch Or Pledget, Biologically Derived

FDA classification
FDA Class 2 ·Intracardiac Patch Or Pledget, Biologically Derived

Manual Blood Grouping And Antibody Test Systems

FDA classification
FDA Class 2 ·Manual Blood Grouping And Antibody Test Systems

Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree

FDA classification
FDA Class 2 ·Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree

Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography

FDA classification
FDA Class 2 ·Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography

Test, Factor Ii G20210a Mutations, Genomic Dna Pcr

FDA classification
FDA Class 2 ·Test, Factor Ii G20210a Mutations, Genomic Dna Pcr

Test, Factor V Leiden Mutations, Genomic Dna Pcr

FDA classification
FDA Class 2 ·Test, Factor V Leiden Mutations, Genomic Dna Pcr

Implanted Subcutaneous Securement Catheter

FDA classification
FDA Class 2 ·Implanted Subcutaneous Securement Catheter

Non-Invasive Vagus Nerve Stimulator - Headache

FDA classification
FDA Class 2 ·Non-Invasive Vagus Nerve Stimulator - Headache