20 results · 16ms · Sources: EU EUDAMED, US FDA

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·LSX EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·LASERSCAN LSX EXCIMER LASER

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·LASERSCAN LSX EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·LASERSCAN LSX EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·LASERSCAN LSX EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·LASER SCAN LSX EXCIMER LASER

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

FDA Pre-Market Approval
FDA Class 3 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

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

FDA Pre-Market Approval
FDA Class 3 ·DIMENSION FPSA FLEX REAGENT CARTRIDGE

Controller, Closed-Loop, Blood-Pressure

FDA Pre-Market Approval
FDA Class 3 ·TITRATOR{TM} MODEL 10K

Controller, Closed-Loop, Blood-Pressure

FDA Pre-Market Approval
FDA Class 3 ·TITRATOR{TM} MODEL 10K

Controller, Closed-Loop, Blood-Pressure

FDA Pre-Market Approval
FDA Class 3 ·TITRATOR{TM} MODEL 10K

Controller, Closed-Loop, Blood-Pressure

FDA Pre-Market Approval
FDA Class 3 ·TITRATOR MODEL 10K

Controller, Closed-Loop, Blood-Pressure

FDA Pre-Market Approval
FDA Class 3 ·TITRATOR{TM} MODEL 10K

Controller, Closed-Loop, Blood-Pressure

FDA Pre-Market Approval
FDA Class 3 ·TITRATOR{TM} MODEL 10K

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·PASYS, PASYS ST, SPECTRAX S, SPECTRAX SX, SPECTRAX SX-HT, SPECTRAX SXT, SYMBIOS, SYNERGYST

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·PASYS, PASYS ST, SPECTRAX S, SPECTRAX SX, SPECTRAX SX-HT, SPECTRAX SXT, SYSMBIOS, SYNERGYST

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·LASERSIGHT LASERSCAN LSX EXCIMER LASER SYSTEM FOR LASER-ASSITED IN SITU KERATOMILEUSIS (LASIK)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·PASYS,PASYS ST,SPECTRAX S,SPECTAX SX,SPECTRAX SX-HT,SPECTRAX SXT,SYMBIOS,SYMBIOS(AA),SYNERGYST

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval
FDA Class 3 ·FNLN2 SXP BP, FNLN2 SXP PF BP, FNLN2 SX PF BP, FNLN2 SXP J BP,

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM G4TM PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM