1,083 results · 40ms · Sources: EU EUDAMED, US FDA

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ASSORTED MOD. C LOOPS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ASSORTED MOD. C LOOPS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC(R) MODELS 9710/9710A ,MOD.2038 MODIFICAT

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval
FDA Class 3 ·DARDIK BIOGRAFT(R) MOD. HUMAN UMBILICAL VEIN GRAFT

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·CROSS SAIL CORONARY DILATATION CATHETER

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL P-17 MOD. C LOOP W/NOTCH POSTERIOR CHAMBER

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ESSENTIO Models L100, L101, L121; PROPONENT Models L200, L201, L221; ACCOLADE Models L300, L301, L321; PROPONENT MRI Mod

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS TOTAL PSA IMMUNOASSAY

Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum

FDA Pre-Market Approval
FDA Class 3 ·AFP MID-PREGNANCY REFERENCE PREPARATION

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MED-EL COCHLEAR IMPLANT SYSTEMS (COMBI40+, PULSARCI100, SONATATI100, MED-EL CONCERT, & MED-EL CONCERT PIN)

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT FREE PSA ASSAY

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT ARCHITECT TOTAL PSA ASSAY

Device, Testicular Hypothermia

FDA Pre-Market Approval
FDA Class 3 ·REPRO-MED - THD

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·Rotlex IOLA MFD

Device, Testicular Hypothermia

FDA Pre-Market Approval
FDA Class 3 ·REPRO-MED - THD

Device, Testicular Hypothermia

FDA Pre-Market Approval
FDA Class 3 ·REPRO-MED - THD

Device, Testicular Hypothermia

FDA Pre-Market Approval
FDA Class 3 ·REPRO-MED - THD

Device, Testicular Hypothermia

FDA Pre-Market Approval
FDA Class 3 ·REPRO-MED - THD

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MED-EL CI System

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MED-EL Cochlear Implant