6,153 results · 45ms · Sources: EU EUDAMED, US FDA

Bolle

FDA registration
PLASTINAX AUSTRAL LTD·1 product·🇲🇺 Mauritius

NATEC MEDICAL LTD

FDA registration
NATEC MEDICAL LTD·2 products·🇲🇺 Mauritius

Tamarin Blue PTCA Rx Dilatation Catheter

FDA registration
NATEC MEDICAL LTD·1 product·🇲🇺 Mauritius

Tamarin Blue PTCA Catheters

FDA registration
NATEC MEDICAL LTD (Maurister)·1 product·🇲🇺 Mauritius

GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST

FDA 510(k)
FDA Class 1 ·Microbiology

GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820

FDA 510(k)
FDA Class 1 ·Microbiology

AFFIRM VP MICROBIAL ID TEST FOR TRICHOMONAS VAGINA

FDA 510(k)
FDA Class 1 ·Microbiology

ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM.

FDA 510(k)
FDA Class 1 ·Microbiology

ACCUPACE GROUP A STREPTOCOCCUS ID TEST

FDA 510(k)
FDA Class 1 ·Microbiology

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·DIASORIN ETI-MAK-2PLUS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ETI-AB-AUK PLUS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ETI-AB-AUK PLUS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ETI-MAK-2 PLUS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ETI-AB-AUK-PLUS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ETI-MAK-2 PLUS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ETI-AB-AUK PLUS

ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544, ONTRAK TESTCUP M2K AND ONTRAK TESTSTICK NEGATIV

FDA 510(k)
FDA Class 1 ·Clinical Toxicology

Coag-Sense Prothrombin Time (PT) /INR Monitoring System

Device
EU IVDD · Eu Ivd General ·CoaguSense Inc.·On the market

Coag-Sense Prothrombin Time (PT)/INR Test Strip Kit

Device
EU IVDD · Eu Ivd General ·CoaguSense Inc.·On the market

Coag-Sense Prothrombin Time (PT)/INR Test Strip Kit

Device
EU IVDD · Eu Ivd General ·CoaguSense Inc.·On the market