Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ADATO SIL-OIL 5000 SILICONE OIL

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval

FDA Class 3 ·Superion Indirect Decompression System

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ADATOMED SILICONE OIL OP5000

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ADATO SIL OL 5000 SILICONE OIL

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ADATO SIL-OL 5000 SILICONE OIL

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ADATO SIL-OL 5000 SILICONE OIL

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ADATO SIL-OL 5000 SILICONE OIL

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ADATO SIL-O1 5000 SILICONE OIL

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ADATO SIL-OL 5000 SILICONE OIL

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ADATO SIL-OL 5000 SILICONE OIL

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ADATO SIL-OL 5000 SILICONE OIL

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ADATO SIL-OL 5000 SILICONE OIL

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ADATO Sil-Ol 5000 Silicone Oil

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ADATO SIL-OL 5000 SILICONE OIL SYRINGE

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ADATO SIL-OL 5000 SILICONE OIL WITH SYRINGE (CATALOG NUMBER: ES 5000 S)

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BREATH TEK UBT FOR H PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PHUR-CA)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Accessory Medical Adhesive, Accessory Mineral Oil, Accessory Vein Pick, Accessory Kit Lead Cap, Accessory Stylet TAPER 0

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

FDA Pre-Market Approval

FDA Class 3 ·CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Excellence SS+ Lead, and Vitatron Impulse II Le

ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG)

FDA 510(k)

FDA Class 3 ·Cardiovascular