PASCO MIC AND MIC/ID PANELS

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App

FDA 510(k)

FDA Class 2 ·Microbiology

BD ECLIPSE HYPODERMIC NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

CARDIAC OUTPUT COMPUTER (MODEL COC-100)

FDA 510(k)

FDA Class 2 ·Cardiovascular

BD ORAL/ENTERAL SYRINGE WITH BD UNIVIA CONNECTION

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

Lucitone Digital Value

FDA UDI

Dentsply International Inc.·D0039062200·

Lucitone

FDA UDI

Dentsply International Inc.·D0019064030·PRIMEPRINT LUCITONE DIGITAL PRINT DENTURE BASE ...

Lucitone

FDA UDI

Dentsply International Inc.·D0019064040·PRIMEPRINT LUCITONE DIGITAL PRINT DENTURE BASE ...

Lucitone

FDA UDI

Dentsply International Inc.·D0019064020·PRIMEPRINT LUCITONE DIGITAL PRINT DENTURE BASE ...

Lucitone

FDA UDI

Dentsply International Inc.·D0019064050·PRIMEPRINT LUCITONE DIGITAL VALUE TRIAL PLACEME...

Lucitone

FDA UDI

Dentsply International Inc.·D0019064010·PRIMEPRINT LUCITONE DIGITAL PRINT DENTURE BASE ...

CE-2137-R

Basic UDI-DI

EU MDR · Eu Md Class 1 ·MOBERCAS SL·1 device

10000374940-PA-NA-KOR

Certificate

MDD Annex II (excluding section 4)·Healcerion Co., Ltd.·DNV Product Assurance AS·2 Basic UDI-DIs

10000374940-PA-NA-KOR R

Certificate

MDD Annex II (excluding section 4)·Healcerion Co., Ltd.·DNV Product Assurance AS·1 Basic UDI-DI

MODEL 7620 LINE CLAMP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System

FDA 510(k)

FDA Class 2 ·Microbiology

CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System

FDA 510(k)

FDA Class 2 ·General Hospital

IQMS/00001/0v002

Certificate

IVDR QMS·Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.·QMD Services GmbH