Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set

FDA 510(k)

FDA Class 2 ·Microbiology

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls

FDA 510(k)

FDA Class 2 ·Microbiology

Access PCT, Access PCT Calibrators

FDA 510(k)

FDA Class 2 ·Microbiology

Hemodialyzer With Expanded Solute Removal Profile

FDA classification

FDA Class 2 ·Hemodialyzer With Expanded Solute Removal Profile

Tube, Tympanostomy With Semi-Permeable Membrane

FDA classification

FDA Class 2 ·Tube, Tympanostomy With Semi-Permeable Membrane

Titrimetric With Edta And Indicator, Calcium

FDA classification

FDA Class 2 ·Titrimetric With Edta And Indicator, Calcium

N95 Respirator With Antimicrobial/Antiviral Agent

FDA classification

FDA Class 2 ·N95 Respirator With Antimicrobial/Antiviral Agent

Enteral Syringes With Enteral Specific Connectors

FDA classification

FDA Class 2 ·Enteral Syringes With Enteral Specific Connectors

Catheter, Retention, Barium Enema With Bag

FDA classification

FDA Class 2 ·Catheter, Retention, Barium Enema With Bag

Esophageal Sheath With Distal Balloon Anchor

FDA classification

FDA Class 2 ·Esophageal Sheath With Distal Balloon Anchor

Adjunctive Hemodynamic Indicator With Decision Point

FDA classification

FDA Class 2 ·Adjunctive Hemodynamic Indicator With Decision Point

Surgical Mask With Antimicrobial/Antiviral Agent

FDA classification

FDA Class 2 ·Surgical Mask With Antimicrobial/Antiviral Agent

Gastrointestinal Tubes With Enteral Specific Connectors

FDA classification

FDA Class 2 ·Gastrointestinal Tubes With Enteral Specific Connectors

Unit, Electrosurgical And Coagulation, With Accessories

FDA classification

FDA Class 2 ·Unit, Electrosurgical And Coagulation, With Accessories

Unit, X-Ray, Extraoral With Timer

FDA classification

FDA Class 2 ·Unit, X-Ray, Extraoral With Timer

System, External Fixator (With Metallic Invasive Components)

FDA classification

FDA Class 2 ·System, External Fixator (With Metallic Invasive Components)

Single Needle With Uni-Directional Pump Kit

FDA classification

FDA Class 2 ·Single Needle With Uni-Directional Pump Kit

Intervertebral Fusion Device With Integrated Fixation, Cervical

FDA classification

FDA Class 2 ·Intervertebral Fusion Device With Integrated Fixation, Cervical

Esophageal Dilator With Balloon And Electrode Sensors

FDA classification

FDA Class 2 ·Esophageal Dilator With Balloon And Electrode Sensors

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA classification

FDA Class 2 ·Intervertebral Fusion Device With Bone Graft, Lumbar