SYNTRA + DIALYZER, MODEL 200

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ULTRAFILTRATION CONTROLLER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HIGH PERMEABILITY DIALYER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)

FDA 510(k)

FDA Class 2 ·Radiology

WellCare Anoscope

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Disposable Medical Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Pusen Eview Medical Video Endoscope Image Processor

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Non-Contact Forehead Thermometer (Models UT306H & UT308H)

FDA 510(k)

FDA Class 2 ·General Hospital

CELL SWEEP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Non-Contact Forehead Thermometer (UT30H)

FDA 510(k)

FDA Class 2 ·General Hospital

Handheld Pulse Oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS TAQMAN HCV TEST FOR USE WITH THE HIGH PURE SYSTEM COBAS AMPLIPREP/COBAS TAQMAN HCV V2.0

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST/COBAS TAQMAN HCV TEST FOR USE WITH THE HIGH PURE SYSTEM, V2.0

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, COBAS TAQMAN HCV TEST,V2.0 FOR USE WITH THE HIGH PURE SYSTEM

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST AND COBAS TAQMAN HCV TEST FOR USE WITH THE HIGH PURE SYSTEM

Invitae Common Hereditary Cancers Panel

FDA 510(k)

FDA Class 2 ·Pathology

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS TAQMAN HCV TEST V2.0 FOR USE WITH THE HIGH PURE SYSTEM AND COBAS AMPLIPREP/BOBAS TAQMAN HCV TEST

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, COBAS TAQMAN HCV TEST, V 2.0 FOR USE WITH THE HIGH PURE SYSTEM