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

AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP

FDA 510(k)
FDA Class 3 ·Cardiovascular

DJP UNIPOLAR

FDA 510(k)
FDA Class 3 ·Cardiovascular

AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP

FDA 510(k)
FDA Class 3 ·Cardiovascular

RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777

FDA 510(k)
FDA Class 3 ·Cardiovascular

MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP

FDA 510(k)
FDA Class 3 ·Cardiovascular

LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP

FDA 510(k)
FDA Class 3 ·Cardiovascular

LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 45-UP

FDA 510(k)
FDA Class 3 ·Cardiovascular

LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UP

FDA 510(k)
FDA Class 3 ·Cardiovascular

SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120 438 AND 120 143

FDA 510(k)
FDA Class 3 ·Cardiovascular

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,

RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 000

FDA 510(k)
FDA Class 3 ·Cardiovascular

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·GELFOAM ABLSORBABLE GELATIN SPONGE AND GELFILM STERILE FILM

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval
FDA Class 3 ·TRULIGN TORIC WEB-BASED TORIC CALCULATOR

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval
FDA Class 3 ·enVista One-Piece Hydrophobic Acrylic Toric Intraocular Lens (Model MX60T)

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval
FDA Class 3 ·TRULIGN TORIC WEB BASED TORIC CALCULATOR

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval
FDA Class 3 ·TECNIS Toric 1-Piece Intraocular Lenses (IOL)

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval
FDA Class 3 ·ELASTIC AND ELASTIMIDE ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval
FDA Class 3 ·CRYSTALENS AND TRULIGN TORIC INTRAOCULAR LENSES (IOLS)

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval
FDA Class 3 ·UV-ABSORBING SILICONE POSTERIOR CHAMBER IOLS W/TORIC OPTIC

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval
FDA Class 3 ·TECNIS TORIC 1-PIECE IOL, MODEL ZCT375