System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·AUTOBAC MIC TEST SYSTEM

Panels, Test, Susceptibility, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·MIC PANELS

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·CIBA CORNING ACS PSA IMMUNOASSAY

Permanently Mounted Wheelchair Platform Lift

FDA classification

FDA Class 2 ·Permanently Mounted Wheelchair Platform Lift

Prophecy Preoperative Navigation Alignment System

FDA 510(k)

FDA Class 2 ·Orthopedic

LOCATOR Angled Abutment (Various)

FDA 510(k)

FDA Class 2 ·Dental

LOCATOR Angled Abutment

FDA 510(k)

FDA Class 2 ·Dental

MTA2.2 MATERIAL

FDA 510(k)

FDA Class 2 ·Dental

PROPHECY Preoperative Navigation Alignment System

FDA 510(k)

FDA Class 2 ·Orthopedic

Cirrus Resting State fMRI Software

FDA 510(k)

FDA Class 2 ·Radiology

Multiflex Tinnitus Technology

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ULTRASAFE PASSIVE NEEDLE GUARD

FDA 510(k)

FDA Class 2 ·General Hospital

INJECTOR, INSULIN

FDA 510(k)

FDA Class 2 ·General Hospital

Ambra PACS

FDA 510(k)

FDA Class 2 ·Radiology

Suture, Surgical, Absorbable, Polydioxanone

FDA Pre-Market Approval

FDA Class 2 ·PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED

MTA2 ROOT AND PULP MATERIALS

FDA 510(k)

FDA Class 2 ·Dental

SUDORMED SWEAT PATCH SPECIMEN CONTAINER: COCAINE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NUWAV

FDA 510(k)

FDA Class 2 ·Radiology

SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRATION

FDA 510(k)

FDA Class 2 ·Clinical Chemistry