Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·TEROX RV /KAINOX SL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR/LEAD MODELS

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

FDA Pre-Market Approval

FDA Class 2 ·S-ROM POLY-DIAL CONSTRAINED ACETABULAR LINER

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·OSTEOSPACE

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·CLARIS(TM) REWETTING DROPS

Eustachian Tube Balloon Dilation Device

FDA classification

FDA Class 2 ·Eustachian Tube Balloon Dilation Device

Reprocessed Atherectomy Catheter

FDA classification

FDA Class 2 ·Reprocessed Atherectomy Catheter

Enzyme Immunoassay, Cortisol, Salivary

FDA classification

FDA Class 2 ·Enzyme Immunoassay, Cortisol, Salivary

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HCV ON CENTAUR CP

Bassinet, Hospital

FDA classification

FDA Class 2 ·Bassinet, Hospital

General Laparoscopic Power Morcellation Containment System

FDA classification

FDA Class 2 ·General Laparoscopic Power Morcellation Containment System

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS TX 2000 VP CORONARY DILATATION CATHETER CAHTETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA CATHETERS

Suture, Surgical, Absorbable, Polydioxanone

FDA Pre-Market Approval

FDA Class 2 ·PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R)BALLOON DILATATION CATH. W/PETELITE(TM)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS RX LIFESTREAM

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·RAPIDSCREEN RS-2000D

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·HA-IGMK RIA ASSAY/ETI-HA-IGMK PLUS

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT ANTI-HCV

Suture, Nonabsorbable, Synthetic, Polypropylene

FDA Pre-Market Approval

FDA Class 2 ·GORE-TEX(TM) SUTURE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGE CHECKER M1000 SYSTEM