1,390 results · 39ms · Sources: EU EUDAMED, US FDA

MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS

FDA 510(k)
FDA Class 2 ·Orthopedic

STRYKER CEMENT REMOVAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

PROSTHETIC CEMENT REMOVER

FDA 510(k)
FDA Class 2 ·Orthopedic

AUTOMATED ENDOSCOPE LEAK TESTER

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

Piccolo Potassium Test System

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR

FDA 510(k)
FDA Class 2 ·Orthopedic

ACRYL-X II SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Chemistry Analyzer Model: ACCENT S120

Device
EU IVDR · Eu Ivd Class A ·PZ CORMAY Spółka Akcyjna·On the market·1 country

Chemistry Analyzer Model: ACCENT S120

Device
EU IVDR · Eu Ivd Class A ·PZ CORMAY Spółka Akcyjna·On the market

CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h > 400 and <= 800)

Device
EU IVDR · Eu Ivd Class A ·PZ CORMAY Spółka Akcyjna·On the market

CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)

Device
EU IVDR · Eu Ivd Class A ·PZ CORMAY Spółka Akcyjna·On the market

CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)

Device
EU IVDR · Eu Ivd Class A ·PZ CORMAY Spółka Akcyjna·On the market

CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)

Device
EU IVDR · Eu Ivd Class A ·PZ CORMAY Spółka Akcyjna·On the market

Lymph Node Location System During Sentinel Biopsy Procedure

FDA Pre-Market Approval
FDA Class 3 ·Magtrace and Sentimag Magnetic Locatization System (PUV)

Kurin PIV (Peripheral IntraVenous) Connection, w/BD Vacutainer

FDA UDI
Kurin, Inc.·00857606008042·

Kurin PIV (Peripheral IntraVenous) Connection, w/ BioMerieux Shield

FDA UDI
Kurin, Inc.·00857606008097·

Lymph Node Location System During Sentinel Biopsy Procedure

FDA Pre-Market Approval
FDA Class 3 ·Magtrace® and Sentimag® Magnetic Locatization System (PUV)

Lymph Node Location System During Sentinel Biopsy Procedure

FDA Pre-Market Approval
FDA Class 3 ·Magtrace® and Sentimag® Magnetic Locatization System (PUV)

MOL3655 Simplexa VZV Swab Direct

FDA registration
DiaSorin Molecular LLC·2 products·🇺🇸 United States