SIGMA DELTA

FDA 510(k)

FDA Class 2 ·Anesthesiology

MODEL CNA-1 VAPORIZER

FDA 510(k)

FDA Class 2 ·Anesthesiology

C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61

FDA 510(k)

FDA Class 2 ·Anesthesiology

DAVOL ATS

FDA 510(k)

FDA Class 2 ·Anesthesiology

RECEPTAL ATS MEDIASTINAL LINER

FDA 510(k)

FDA Class 2 ·Anesthesiology

DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS

FDA 510(k)

FDA Class 2 ·Anesthesiology

Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye Contact Lens Case

FDA 510(k)

FDA Class 2 ·Ophthalmic

Corsano CardioWatch 287-2 System

FDA 510(k)

FDA Class 2 ·Cardiovascular

MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra

FDA 510(k)

FDA Class 2 ·Physical Medicine

Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)

FDA 510(k)

FDA Class 2 ·Dental

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Vaporizer, Anesthesia, Non-Heated

FDA classification

FDA Class 2 ·Vaporizer, Anesthesia, Non-Heated

Apparatus, Autotransfusion

FDA classification

FDA Class 2 ·Apparatus, Autotransfusion

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ORACLE MEGASONICS FIVE-64 PTCA CATHETER

Over The Counter Thermal Treatment For Acne.

FDA classification

FDA Class 2 ·Over The Counter Thermal Treatment For Acne.

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·OPTI-FREE RINSING,DISINFECTING,& STORAGE SOLUTION

Lens, Contact (Orthokeratology)

FDA Pre-Market Approval

FDA Class 2 ·FLUOROPERM 60 RIGID GAS PERMEABLE CONTACT LENSES

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Aptima HCV Quant Dx Assay

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·APTIMA HCV RNA QUALITATIVE ASSAY