921 results · 24ms · Sources: EU EUDAMED, US FDA

Sharps Needle Destruction Device

FDA Pre-Market Approval
FDA Class 2 ·DISINTEGRATOR PRO NEEDLE DESTRUCTION DEVICE

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·SODIUM CHLORIDE TABLETS, USP

NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY

FDA 510(k)
FDA Class 2 ·Immunology

PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

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

FDA Pre-Market Approval
FDA Class 2 ·Elecsys free PSA Test System

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

FDA Pre-Market Approval
FDA Class 2 ·Elecsys free PSA Test System

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

FDA Pre-Market Approval
FDA Class 2 ·Elecsys free PSA

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 ·IMMULITE/IMMULITE 1000 PSA & 1000 THIRD GENERATION PSA

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

FDA Pre-Market Approval
FDA Class 2 ·AIA-PACK PA PSA, ST AIA-PACK PA PSA

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

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT AXSYM/TOTAL PSA

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

FDA Pre-Market Approval
FDA Class 2 ·ACCESS HYBRITECH PSA REAGENTS ACCESS IMMUNOASSAY SYSTEMS

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 TPSA FLEX REAGENT CARTRIDGE

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

FDA Pre-Market Approval
FDA Class 2 ·ACCESS HYBRITECH PSA ON THE SYNCHRON LXI 725 SYSTEM

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

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT AXSYM TOTAL PSA

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