Arm Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Sonic DL

FDA 510(k)

FDA Class 2 ·Radiology

BPAP System

FDA 510(k)

FDA Class 2 ·Anesthesiology

MOZI TPS

FDA 510(k)

FDA Class 2 ·Radiology

Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Arm Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

AeviceMD

FDA 510(k)

FDA Class 2 ·Cardiovascular

Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Arm Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Surgical face mask (Model: Flat Ear Loop/CN102)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Disposable Endobronchial Blocker Tube

FDA 510(k)

FDA Class 2 ·Anesthesiology

Arm Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

AeviceMD

FDA 510(k)

FDA Class 2 ·Cardiovascular

InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; InsightersTM Insight Workstation iS-PF1.

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311

FDA 510(k)

FDA Class 2 ·General Hospital

Portable X-ray System Model Ray98(P)

FDA 510(k)

FDA Class 2 ·Dental

Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383

FDA 510(k)

FDA Class 2 ·General Hospital

Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology