2,461 results · 18ms · Sources: EU EUDAMED, US FDA

ZWEYMULLER CUP

FDA 510(k)
FDA Class 3 ·Orthopedic

RS-CUP ACETABULAR PROSTHESIS

FDA 510(k)
FDA Class 3 ·Orthopedic

ZWEYMUELLER-SL HIP PROSTHESIS STEM

FDA 510(k)
FDA Class 3 ·Orthopedic

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODIFIED J & C LLOP POST. CHAMBER INTRAOCULAR LENS

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators and Accessories

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators and Accessories

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·DURASEAL DURAL SEALANT SYSTEM

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·SURGICEL® Absorbable Hemostats (SURGICEL® POWDER™)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·PROVISC Ophthalmic Viscosurgical Device (latex-ftee packaging configuration)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE; DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE (WITH PROVISC IN LATEX-FREE PACK)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Clareon Aspheric Hydrophobic lOL; Clareon PanOptix Hydrophobic lOL; and Clareon Toric Aspheric Hydrophobic lOL

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·DISCOVISC™ Ophthalmic Viscosurgical Device

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·DURASEAL DURAL SEALANT SYSTEM

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·OL1000/OL1000 SC AND SPINALOGIC BONE BROWTH STIMULATORS

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·PreveLeak Surgical Sealant & 10pk applictor tips

Stent, Urethral, Prostatic, Semi-Permanent

FDA Pre-Market Approval
FDA Class 3 ·THE SPANNER TEMPORARY PROSTATIC STENT