Burke

FDA UDI

BURKE, INC.·B31463398B1·Bariatric Bed

FUSION

FDA 510(k)

FDA Class 2 ·Physical Medicine

COLD/HOT FLUID RADIATION PAD NEUTECH

FDA 510(k)

FDA Class 2 ·Physical Medicine

SCOUT BOSS

FDA 510(k)

FDA Class 2 ·Physical Medicine

PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE)

FDA 510(k)

FDA Class 2 ·Physical Medicine

SCOUT

FDA 510(k)

FDA Class 2 ·Physical Medicine

PACESAVER & SCOUT

FDA 510(k)

FDA Class 2 ·Physical Medicine

CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

CONTRAST 7000 THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

THERMAFLEX, MODEL SD 55 C.P.M.H.

FDA 510(k)

FDA Class 1 ·Physical Medicine

NEURO-AIDE

FDA 510(k)

FDA Class 1 ·Neurology

TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

SPORTS CONTRAST THERAPY SYSTEM ST 7000

FDA 510(k)

FDA Class 2 ·Physical Medicine

LSI6000 THERMAL THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

EPILATOR

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

Patient Support Products Pediatric Backpack

FDA registration

BURNING TREE DESIGN INC.·1 product·🇨🇦 Canada

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR HEPATITIS C VIRUS (HCV) TEST

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR HCV TEST