66 results · 8ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·EXCIMED(TM) UV200LA LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·SVS APEX PLUS EXCIMER LASER WORKSTATION

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·SVS APEX PLUS EXCIMER LASER WORKSTATION

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·SVS APEX PLUS EXCIMER LASER WORKSTATION

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

FDA Pre-Market Approval
FDA Class 3 ·AXSYM TOTAL PSA & ARCHITECT TOTAL PSA

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval
FDA Class 3 ·SULFUR HEXAFLUORIDE

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval
FDA Class 3 ·SULFUR HEXAFLUORIDE FOR PNEUMATIC RETINOPEXY

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

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

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

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

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

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT Total PSA (LN 6C06)

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

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

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

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

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

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

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

FDA Pre-Market Approval
FDA Class 3 ·Alinity i Total 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

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

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT TOTAL PSA (LN 6CO6)

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

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

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

FDA Pre-Market Approval
FDA Class 3 ·Axsym Total PSA & Architect Total PSA

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

FDA Pre-Market Approval
FDA Class 3 ·AXSYM TOTAL PSA (LN 3C19)

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

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT TOTAL PSA (LN 6C06)