DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T

FDA 510(k)

FDA Class 2 ·Immunology

1870T PRESSURE TRANSDUCER PRE-AMPLIFIER, 1880 WATE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ELASTIC STYLE IMPERVIOUS ORTHOPEDIC STOCKINET

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PMT HALO SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

1351 UROFLOW AUTO START

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODEL 1712 CATHETER WITHDRAWAL SYS FOR URETHRAL PR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BIOSLEEP

FDA 510(k)

FDA Class 2 ·Neurology

MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw

FDA 510(k)

FDA Class 2 ·Dental

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Elecsys ANti-HCV II (100/200 tests)

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLICOR HEPTATIS C VIRUS (HCV) TEST

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCT ANTI-HCV REAGENT PACK & CALIBRATOR

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)

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

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV

Shoulder Arthroplasty Implantation System

FDA classification

FDA Class 2 ·Shoulder Arthroplasty Implantation System

Knee Arthroplasty Implantation System

FDA classification

FDA Class 2 ·Knee Arthroplasty Implantation System

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·RAPTORAIL PTCA DILATATION CATHETER (RX)

Multiple Use Blood Lancet For Single Patient Use Only

FDA classification

FDA Class 2 ·Multiple Use Blood Lancet For Single Patient Use Only

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·cobas CMV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS AmpliPrep/COBAS TaqMan CMV Test

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Elecsys free PSA Test System