Empulse M90

FDA 510(k)

FDA Class 2 ·Physical Medicine

ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)

Cap, Cervical

FDA classification

FDA Class 2 ·Cap, Cervical

Alpha-D-Glucosidase (Gaa) Newborn Screening Test System

FDA classification

FDA Class 2 ·Alpha-D-Glucosidase (Gaa) Newborn Screening Test System

Kit, Conception-Assist, Home Use

FDA classification

FDA Class 2 ·Kit, Conception-Assist, Home Use

Cap, Device Disinfectant

FDA classification

FDA Class 2 ·Cap, Device Disinfectant

Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

FDA classification

FDA Class 2 ·Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

Hemodialysis Catheter Luer End Cap

FDA classification

FDA Class 2 ·Hemodialysis Catheter Luer End Cap

Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Procalcitonin Assay

FDA classification

FDA Class 2 ·Procalcitonin Assay

In Situ Polymerizing Peripheral Nerve Cap

FDA classification

FDA Class 2 ·In Situ Polymerizing Peripheral Nerve Cap

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SOFT CONTACT LENS

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER MODELS MFL5000 MOBILE LITHOTRIPTER