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

FDA Pre-Market Approval

FDA Class 2 ·Dimension® TPSA Flex® reagent cartridge

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

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

FDA Class 2 ·Dimension® TPSA Flex® reagent cartridge

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

FDA Pre-Market Approval

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

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·FLEX-CARE(R) RINSING, DISINFECTING, AND STORAGE SOLUTION

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

FDA Pre-Market Approval

FDA Class 2 ·DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGE

SABA Tampons

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AURADORM (NEUROMUSCULAR SLEEP)

FDA 510(k)

FDA Class 2 ·Dental

FLEXCATH STEERABLE SHEATH & DILATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEGVISION, MODEL EQ1000C SERIES

FDA 510(k)

FDA Class 2 ·Neurology

Reagents, Test, Bromides

FDA classification

FDA Class 2 ·Reagents, Test, Bromides

Implant, Subperiosteal

FDA classification

FDA Class 2 ·Implant, Subperiosteal

MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

M-60 GOLD BASE DENTAL ALLOY

FDA 510(k)

FDA Class 2 ·Dental

ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER

FDA 510(k)

FDA Class 2 ·General Hospital

TYCHE PEDICLE SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

IPL hair removal device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CALCIUM REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EOS SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

RESCUE EXTERNAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental