AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Merge Hemo

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDIGUIDE TECHNOLOGY

FDA 510(k)

FDA Class 2 ·Cardiovascular

SUPRAPUBIC CATHETER AND INTRODUCER SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NON-CONTACT FOREHEAD INFRARED THERMOMETER, MODEL DT-8806H, BODY INFRARED THERMOMETER, MODEL DT-8806 AND DIGITAL INFRARED

FDA 510(k)

FDA Class 2 ·General Hospital

MEDIN TECH ZIRCONIA-CP10, SS1000

FDA 510(k)

FDA Class 2 ·Dental

STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SOFT SACK IV FLUID WARMER, THE FLOORMOUNT IV FLUID WARMER, THE PAK 2 IV WARMER AND THE THERMAL SAC PRESSURE INFUSER

FDA 510(k)

FDA Class 2 ·General Hospital

Sparse Sample Pk Profile And Dosing Software

FDA classification

FDA Class 2 ·Sparse Sample Pk Profile And Dosing Software

INTERMITTENT PNEUMATIC COMPRESSION DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Computer, Diagnostic, Programmable

FDA classification

FDA Class 2 ·Computer, Diagnostic, Programmable

Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241

FDA 510(k)

FDA Class 2 ·General Hospital

Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CO2 Laser Machine (Lume)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Computerized Cognitive Assessment Aid, Exempt

FDA classification

FDA Class 2 ·Computerized Cognitive Assessment Aid, Exempt

Labware, Assisted Reproduction, Exempt

FDA classification

FDA Class 2 ·Labware, Assisted Reproduction, Exempt