Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·SPINAL CORD STIMULATION (SCS) INPLANTABLE NEUROSTIMULATORS (INS) RESTORE FAMILY

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·GORE CARDIOFORM SEPTAL OCCLUDER SHARED HLC IN-LINE DIPPER

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

FDA Pre-Market Approval

FDA Class 3 ·BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGG IN VITRO DIAGNOSTIC DEVICE

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN PACT ADMIRAL PACLITAXEL-COATING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLON CATHETER

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN PACT ADMIRAL PACLITAXEL-COATING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN-PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN PACT ADMIRAL PACLITAXEL-Coated PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER

Fluid, Hysteroscopy

FDA Pre-Market Approval

FDA Class 3 ·HYSKON HYSTEROSCOPY FLUID 32% (W/V) DEXTRAN 70 IN DEXTROSE

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMICAL ANGIOPLASTLY BALLOON CATHETER

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER

THERAPEUTIC EXCHANGE SYSTEM

FDA 510(k)

FDA Class 3 ·Unknown

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Intraocular Lenses (IOLs) in the DaisyWheel and TECNIS SIMPLICITY Delivery System