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

FDA Pre-Market Approval

FDA Class 2 ·TANDEM-MP PSA IMMUNOENZYMETRIC ASSAY

Tabletop Sunlamp System

FDA classification

FDA Class 2 ·Tabletop Sunlamp System

Ankle Arthroplasty Implantation System

FDA classification

FDA Class 2 ·Ankle Arthroplasty Implantation System

Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr

FDA classification

FDA Class 2 ·Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr

Catheter Remote Control System

FDA classification

FDA Class 2 ·Catheter Remote Control System

Breast Implant Suction Retrieval Device

FDA classification

FDA Class 2 ·Breast Implant Suction Retrieval Device

Reduced Ejection Fraction Machine Learning-Based Notification Software

FDA classification

FDA Class 2 ·Reduced Ejection Fraction Machine Learning-Based Notification Software

Bone Fixation Cerclage, Sublaminar

FDA classification

FDA Class 2 ·Bone Fixation Cerclage, Sublaminar

High Throughput Dna Sequence Analyzer

FDA classification

FDA Class 2 ·High Throughput Dna Sequence Analyzer

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS SWAP-IT GUIDE WIRE EXCHANGE DEVICE CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK 2 MONORAIL PTCA CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

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

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·APEX MONORAIL AND OVER-THE-WIRE PTCA DILATATION CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R)TELESCOPE(TM) SINGLE OPERATOR BALLOON

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CHAMPION WRAP PTCA CATHETER

Sealant, Microbial

FDA classification

FDA Class 2 ·Sealant, Microbial

Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software

FDA classification

FDA Class 2 ·Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software

Ventilatory Electrical Impedance Tomograph

FDA classification

FDA Class 2 ·Ventilatory Electrical Impedance Tomograph

Ankle Fusion Cage

FDA classification

FDA Class 2 ·Ankle Fusion Cage