I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MODEL M1175A/M1176A WITH ST SEGMENT MONITORING

FDA 510(k)

FDA Class 2 ·Cardiovascular

Relizorb

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System- Localizer Surgical Probe (5 pack), RFID Localization System- Tag Applicator, RFID Localization System -Tag Applicator (10 pack)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ENDLESSFIBER REUSABLE SURGICAL LASER FIBER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CIBA CORNING ACS FOLATE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

iSLEEVE Introducer Set

FDA 510(k)

FDA Class 2 ·Cardiovascular

STRAUMANN DENTAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

MICRO-INDUCTION 1000 SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MALDI BIOTYPER CA (MBT-CA) SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

CODMAN SKULL PINS (ADULT & CHILD), REUSABLE

FDA 510(k)

FDA Class 2 ·Neurology

STERN ERA ALIGNMENT CORRECTION IMPLANT ABUTMENT

FDA 510(k)

FDA Class 2 ·Dental

NXSTAGE PUREFLOW SOLUTION

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HEMOSIL FACTOR VIII DEFICIENT PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

PULPDENT VLC RESIN CEMENT

FDA 510(k)

FDA Class 2 ·Dental

Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STERILEMED REPROCESSED IVUS IMAGING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable

FDA 510(k)

FDA Class 2 ·Neurology

SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg)

FDA 510(k)

FDA Class 2 ·Cardiovascular