ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

ABX MICROS ES 60 OT and ABX MICROS ES 60 CT

FDA 510(k)

FDA Class 2 ·Hematology

ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MICROS 60

FDA 510(k)

FDA Class 2 ·Hematology

PENTRA XLR

FDA 510(k)

FDA Class 2 ·Hematology

SURPASSON P5 NEWTRON

FDA 510(k)

FDA Class 2 ·Dental

ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABX PENTRA TPU CAL, MODEL A11A01898

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABX PENTRA URINE CAL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Cap, Cervical

FDA classification

FDA Class 2 ·Cap, Cervical

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·BAK INTERBODY FUSION 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

Continuous, Ventilator, Home Use

FDA classification

FDA Class 2 ·Continuous, Ventilator, Home Use

Monitor, Air Embolism, Ultrasonic

FDA classification

FDA Class 2 ·Monitor, Air Embolism, Ultrasonic

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

FDA classification

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

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

Hemodialysis Catheter Luer End Cap

FDA classification

FDA Class 2 ·Hemodialysis Catheter Luer End Cap

Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology