Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC HALL PROSTHETIC HEART VALVE/EASY-FIT/AORTIC VALVED CONDUIT/COLLAGEN IMPREGNATED CONDUIT/ROTATABLE AORTIC

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BreathTek UBT for H. pylori Kit and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA)

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·Rapid fFN Cassette Kit for the TLiIQ System, Rapid fFN Control for the TLiIQ System

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·THERAKOS CELLEX INSTRUMENT, THERAKOS CELLEX PHOTOPHRESSIS PROCEDURAL KIT (125 ML), CLX, THERAKOS CELLEX LIGHT ASSEMBLY ,

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·DRUG DELIVERY ACCESSORIES,DRUG DELIVERY CATHETERS,DRUG DELIVERY INFUSION PUMPS SYNCHROMED FAMILY,DRUG DELIVERY KITS

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval

FDA Class 3 ·Shockwave C2 Intravascular (IVL) Catheter, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

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

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·Medtronic MiniMed 780G insulin pump (MMT-1884), Medtronic MiniMed 780G insulin pump kit (MMT-1894)

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Alinity i Anti-HBc Reagent Kit, Alinity i Anti-HBc Calibrator, Alinity i Anti-HBc Controls

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·IS-1 CONNECTOR PORT PIN PLUG KIT, SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SURESTREAM INTRASPINAL CATHETER KIT (60-2918) & SURESTREAM REPLACEMENT CONNECTOR AND STRAIN RELIEF SLEEVE (60-2950)

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval

FDA Class 3 ·Shockwave C2 Intravascular Lithotripsy (IVL) Catheter, VL Generator and Connector Cable Kit, IVL Connector Cable (Replac

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

FDA Pre-Market Approval

FDA Class 3 ·Adhesive, CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Stylet Kit, Vitatron Crystalline Lead

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·DRUG dELIVERY ACCESSORIES, DRUG DELIVERY CATHETERS, DRUG DELIVERY INFUSION PUMPS SYNCHROMED FAMILY, DRUG DELIVERY KITS F

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGIFLO® Hemostatic Matrix, SURGIFLO® Hemostatic Matrix Kit with Thrombin, SURGIFOAM® Absorbable Gelatin Sponge, U.S.P.

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval

FDA Class 3 ·Shockwave C2/C2+ Intravascular Lithotripsy (IVL) Catheter, IVL Generator and Connector Cable Kit, IVL Connector Cable (r

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

FDA Pre-Market Approval

FDA Class 3 ·Adhesive, CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Stylet Kit and Vitatron Crystalline Lead

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0

Stimulator, Carotid Sinus Nerve

FDA Pre-Market Approval

FDA Class 3 ·BAROSTIM NEO Implantable Pulse Generator (IPG), BAROSTIM NEO Carotid Sinus Lead (CSL) Kit, Programmer System, Carotid Si

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