Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·POSTERIOR & ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·ARISTA AH ABSORBABLE HEMOSTAT

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Pro Flash Glucose Monitoring System

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·BONNIE (TM) PTCA CATHERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED(R)REBEL(TM) PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PAS CHAMPION HP PTCA CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI APOLLO RELY ADDITIONAL SIZES

Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)

FDA classification

FDA Class 1 ·Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)

X-Ray Thickness Gauge

FDA classification

FDA Not Classified ·X-Ray Thickness Gauge

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE SILICONE-FILLED BREAST IMPLANT

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS RX COMET VP (TM) CORONARY DILATATION CATHETER/HYDROCOAT HYDROPHILIC

Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair

FDA classification

FDA Class 2 ·Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair

Bassinet, Hospital

FDA classification

FDA Class 2 ·Bassinet, Hospital

Laser Marker Or Engraver, Industrial Or Commercial

FDA classification

FDA Not Classified ·Laser Marker Or Engraver, Industrial Or Commercial

Oscilloscope (Exempted)

FDA classification

FDA Not Classified ·Oscilloscope (Exempted)

Personnel Security Backscatter X-Ray System

FDA classification

FDA Not Classified ·Personnel Security Backscatter X-Ray System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM, DEXCOM SHARE SYSTEM

Endoscopic Light-Projecting Measuring Device

FDA classification

FDA Class 2 ·Endoscopic Light-Projecting Measuring Device

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SYNERGYST II PULSE GENERATOR

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2800 (PERIMOUNT RSR), 6900P (PERIMOUNT PLUS) AND 3000