POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10

FDA 510(k)

FDA Class 3 ·Cardiovascular

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·CRCDx RAS Mutation Detection Assay Kit

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·Praxis Extended RAS Panel

System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

FDA classification

FDA Class 3 ·System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·therascreen BRAF V600E RGQ PCR Kit

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICAL SNOW ABSORBABLE HEMOSTAT

Sterilizer, Endodontic Dry Heat

FDA classification

FDA Class 3 ·Sterilizer, Endodontic Dry Heat

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLS

MEDILAS 2

FDA 510(k)

FDA Class 3 ·Unknown

NOVATHERM

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

OSCOR MEDICAL IMPLANTABLE PACING LEAD, RETRACTABLE

FDA 510(k)

FDA Class 3 ·Cardiovascular

MULTI-FUNCTION DEFIBRILLATION ELECTRODE

FDA 510(k)

FDA Class 3 ·Cardiovascular

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA classification

FDA Class 3 ·System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

Dc-Defibrillator, High Energy, (Including Paddles)

FDA classification

FDA Class 3 ·Dc-Defibrillator, High Energy, (Including Paddles)

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT REALTIME HBV ASSAY

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LifeVest Wearable Defibrillator

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM SEVEN AND SEVEN PLUS