INNOFLUOR CARBAMAZEPINE REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DATA IV AMBULATORY MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

ORAL POTENTIAL METER (OPM)

FDA 510(k)

FDA Class 2 ·Dental

PENTAX Medical Video Duedenoscope ED34-i10T2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

OLDELFT DIGIDELCA

FDA 510(k)

FDA Class 2 ·Radiology

PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AMBER DU

FDA 510(k)

FDA Class 2 ·Radiology

PENTAX Medical Video Upper GI Scopes EG17-J10

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PCA PERIOCARE PERIODONTAL DRESSING

FDA 510(k)

FDA Class 2 ·Dental

PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ALKALINE PHOSPHATASE MARKER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

OTA COLLAGEN BIOMATERIAL

FDA 510(k)

FDA Class 2 ·Dental