SURGIVISIO Device

FDA 510(k)

FDA Class 2 ·Radiology

CTLOGICS NAVIGATIONS SYSTEMS

FDA 510(k)

FDA Class 2 ·Neurology

TOTAL HIP SURGETICS NAVIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK

FDA 510(k)

FDA Class 2 ·Neurology

SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115

FDA 510(k)

FDA Class 2 ·Orthopedic

MEMOMETAL NAVIS BONE PLATING SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES

FDA 510(k)

FDA Class 2 ·Neurology

OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MEMOMETAL VARISATION, MODELS AV26-08, AV26-10, AV90-08 AND AV90-10

FDA 510(k)

FDA Class 2 ·Orthopedic

MEMOMETAL ANCHORAGE BONE PLATE SYSTEM, MODELS PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50

FDA 510(k)

FDA Class 2 ·Orthopedic

SURGIVISIO Device

FDA 510(k)

FDA Class 2 ·Neurology

SURGIVISIO Device

FDA 510(k)

FDA Class 2 ·Neurology

MEMOMETAL INTRA-MEDULLARY BONE FASTENER, MODELS SMART TOE / X-FUSE

FDA 510(k)

FDA Class 2 ·Orthopedic

UNI KNEE SURGETICS NAVIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

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

FDA Pre-Market Approval

FDA Class 2 ·IMMULITE(R)PSA, IMMULITE(R) THIRD GENERATION PSA, IMMULITE(R) 2000

Monitor, Carbon-Dioxide, Cutaneous

FDA Pre-Market Approval

FDA Class 2 ·MODEL 515 NEONATAL MONIOTR

Glucose Oxidase, Glucose

FDA Pre-Market Approval

FDA Class 2 ·GLUCOWATCH G2 AUTOMATIC GLUCOSE BIOGRAPHER

Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY

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

FDA Pre-Market Approval

FDA Class 2 ·Dimension TPSA Flex reagent cartridge (RF451)

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

FDA Pre-Market Approval

FDA Class 2 ·Dimension Vista TPSA Flex reagent cartridge (K6451)