ß-Glucocerebrosidase (Gba) Newborn Screening Test System

FDA classification

FDA Class 2 ·ß-Glucocerebrosidase (Gba) Newborn Screening Test System

Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

FDA classification

FDA Class 2 ·Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

Cystometric Gas (Carbon-Dioxide) On Hydraulic Device

FDA classification

FDA Class 2 ·Cystometric Gas (Carbon-Dioxide) On Hydraulic Device

Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)

FDA classification

FDA Class 2 ·Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)

Dental Barriers And Sleeves

FDA classification

FDA Class 2 ·Dental Barriers And Sleeves

Breast Milk-Alcohol Test System

FDA classification

FDA Class 2 ·Breast Milk-Alcohol Test System

General Laparoscopic Power Morcellation Containment System

FDA classification

FDA Class 2 ·General Laparoscopic Power Morcellation Containment System

Tether Accessory For Use In The Gastrointestinal Tract

FDA classification

FDA Class 2 ·Tether Accessory For Use In The Gastrointestinal Tract

Cap, Device Disinfectant

FDA classification

FDA Class 2 ·Cap, Device Disinfectant

Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling

FDA classification

FDA Class 2 ·Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling

Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)

FDA classification

FDA Class 2 ·Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)

Insufflator, Endoscopic Vessel Harvesting

FDA classification

FDA Class 2 ·Insufflator, Endoscopic Vessel Harvesting

Orthopaedic Surgical Planning And Instrument Guides

FDA classification

FDA Class 2 ·Orthopaedic Surgical Planning And Instrument Guides

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

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

Bone Fixation Cerclage, Sublaminar

FDA classification

FDA Class 2 ·Bone Fixation Cerclage, Sublaminar

Surgical Planning Software For Neurological Stereotaxic Instruments

FDA classification

FDA Class 2 ·Surgical Planning Software For Neurological Stereotaxic Instruments

Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed

FDA classification

FDA Class 2 ·Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed

Hydrophilic Re-Coating Solution

FDA classification

FDA Class 2 ·Hydrophilic Re-Coating Solution

System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species

FDA classification

FDA Class 2 ·System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species

Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

FDA classification

FDA Class 2 ·Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia