SPECTRUM FIVE LUMEN CENTRAL VENOUS CATHETER SET, MODEL C-UQLM10.0-ABRM

FDA 510(k)

FDA Class 2 ·General Hospital

KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

KING DIAGNOSTICS CHOLESTEROL REAGENT STRIP TEST

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

CALIBRATION KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

KING DIAGNOSTICS LDH TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·myChoice HRD CDx

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·myChoice CDx

System, Identification, Contact Lens

FDA classification

FDA Class 3 ·System, Identification, Contact Lens

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·myChoice CDx

LJH Bio

Manufacturer

🇰🇷 South Korea

LCH MEDICAL PRODUCTS

Manufacturer

🇫🇷 France

OXY-1 System

FDA registration

Breethe, Inc.·4 products·🇺🇸 United States

Joh. Th. Schulte bv

Manufacturer

🇳🇱 Netherlands

Johs. Tandrup A/S

Manufacturer

🇩🇰 Denmark

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS TOTAL PSA IMMUNOASSAY

AutoDELFIA Neonatal 17 a-OH-progesterone (B024-01C, B024-104, B024-112)

FDA registration

WALLAC OY·1 product·🇫🇮 Finland

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT FREE PSA ASSAY

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT ARCHITECT TOTAL PSA ASSAY

BECTON DICKINSON

FDA registration

ALLIED DISTRIBUTION LIMITED·1 product·🇦🇪 United Arab Emirates