Isomedix Operations, Inc.

FDA registration

Isomedix Operations, Inc.·3 products·🇺🇸 United States

Fusion

FDA registration

MONTERIS MEDICAL CORP·3 products·🇺🇸 United States

NeuroBlate

FDA registration

MONTERIS MEDICAL CORP·3 products·🇺🇸 United States

NeuroBlate System

FDA registration

MONTERIS MEDICAL CORP·3 products·🇺🇸 United States

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System (SNS Urinary Neurostimulator)

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System (SNS Bowel Neurostimulator)

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-MAK-2 PLUS and HBsAg Confirmatory Test Assays

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

FDA Pre-Market Approval

FDA Class 3 ·ETI MAK-2 PLUS and HBsAg Confirmatory Test assays

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-MAK-2 PLUS and HBsAg Confirmatory Test Assays

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

FDA Pre-Market Approval

FDA Class 3 ·ETI MAK-2 PLUS and HBsAg Confirmatory Test assays

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-MAK-2 PLUS and HBsAg Confirmatory Test assay

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

FDA Pre-Market Approval

FDA Class 3 ·ETI MAK-2 PLUS Assay and HBsAg Confirmatory Test

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-MAK-2 PLUS and HBsAg Confirmatory Test assays

Vinyl Silicone Material

FDA registration

CROWN DELTA CORP.·1 product·🇺🇸 United States

t:slim X2 with Basal-IQ Technology

FDA registration

TANDEM DIABETES CARE, INC.·2 products·🇺🇸 United States

IMMUNO-BIOLOGICAL LABORATORIES, INC.

FDA registration

IMMUNO-BIOLOGICAL LABORATORIES, INC.·1 product·🇺🇸 United States

TRITEX MEDICAL MANUFACTURING LLC

FDA registration

TRITEX MEDICAL MANUFACTURING LLC·1 product·🇺🇸 United States

BluTab Waterline Maintenance Tablets

FDA registration

PROEDGE DENTAL PRODUCTS·1 product·🇺🇸 United States

PULSE TECHNOLOGIES, INC.

FDA registration

PULSE TECHNOLOGIES, INC.·2 products·🇺🇸 United States

High Sensitivity Salivary Cotinine Quantitative Enzyme Immunoassay Kit

FDA registration

SALIMETRICS LLC.·1 product·🇺🇸 United States