PRISMAFLEX M150 SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

FDA Pre-Market Approval

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

NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE

FDA 510(k)

FDA Class 2 ·Neurology

CAS PSI SHOULDER

FDA 510(k)

FDA Class 2 ·Orthopedic

IASSIST KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

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

FDA Pre-Market Approval

FDA Class 2 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

DiaFil Flow

FDA 510(k)

FDA Class 2 ·Dental

DIA-ROOT BIO Sealer

FDA 510(k)

FDA Class 2 ·Dental

DiaPaste

FDA 510(k)

FDA Class 2 ·Dental

DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit

FDA 510(k)

FDA Class 2 ·Dental

Dia-Cem

FDA 510(k)

FDA Class 2 ·Dental

DIAFIL & DIAFIL Capsule

FDA 510(k)

FDA Class 2 ·Dental

DIAPLUS Universal

FDA 510(k)

FDA Class 2 ·Dental

DiaPlus

FDA 510(k)

FDA Class 2 ·Dental

D-LUX+

FDA 510(k)

FDA Class 2 ·Dental

DiaTemp

FDA 510(k)

FDA Class 2 ·Dental