535 results · 35ms · Sources: EU EUDAMED, US FDA

FDA Pre-Market Approval
INSYNC III/II MARQUIS/INSYNC SENTRY/MAXIMO ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MARQUIS/MAXIMO/INTRINSIC ICDS

Gonococcal Antibody Tests

FDA Pre-Market Approval
FDA Class 3 ·FLUORESCENT GONORRHEA TEST-HEATED (FGT-H)

Stimulator, Autonomic Nerve, Implanted (Depression)

FDA Pre-Market Approval
FDA Class 3 ·VNS THERAPY SYSTEM PULSE GENERATORS

FDA Pre-Market Approval
MediBeacon® Transdermal GFR Measurement System (TGFR)

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·STELID II BFT/BJF/STELIX BR/STELIX II BRF

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·STELID II BFT/BJF/STELIX BR/STELIX II BRF

Cap, Cooling (Infants)

FDA Pre-Market Approval
FDA Class 3 ·OLYMPIC COOL-CAP SYSTEM

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval
FDA Class 2 ·FLUOREX (TM) 600 (FLURSILFOCON A)

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval
FDA Class 2 ·8LUOREX (TM) 600 (FLURSILFOCON A)

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval
FDA Class 2 ·8LUOREX (TM) 600 (FLURSILFOCON A)

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval
FDA Class 2 ·FLUOREX(TM) FLUSILFOCON) 700,500,300 RGP LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval
FDA Class 2 ·FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval
FDA Class 2 ·FLUOREX(TM) FFLUSILFOCON) 700,500,300 RGP LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval
FDA Class 2 ·FLUOREX (TM) 600 (FLURSILFOCON A)

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval
FDA Class 2 ·FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval
FDA Class 2 ·FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval
FDA Class 2 ·FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval
FDA Class 2 ·8LUOREX (TM) 600 (FLURSILFOCON A)

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval
FDA Class 2 ·FLUOREX (TM) 600 (FLURSILFOCON A)