ARCHITECT STAT CK-MB IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ELEKTA OY

FDA 510(k)

FDA Class 2 ·Neurology

ORAJEL ADVANCED TOOTH DESENSITIZER

FDA 510(k)

FDA Class 2 ·Dental

NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION

FDA 510(k)

FDA Class 2 ·Dental

ARCHITECT STAT TROPONIN-1; MYOGLOBIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARCHITECT STAT MYO IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ARCHITECT STAT TROPONIN-I IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

1-Step Culture Medium

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BX VELOCITY(TM) WITH HEPACOAT(TM) ON RAPTOR (TM) STENT SYSTEM FOR CORONARY ARTERIES

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·(MBX, MHY, NHL, PJS) -Master Percept and Activa Deep Brain Stimulation Therapy Systems

PLEUR-EVAC

FDA registration

Sterigenics US LLC·1 product·🇺🇸 United States

Radiaxon®

FDA UDI

INNOVATIVE HEALTHCARE CORPORATION·10813172025149·Gloves, Radiation Attenuation, Latex, 6.0

Radiaxon®

FDA UDI

INNOVATIVE HEALTHCARE CORPORATION·10813172025156·Gloves, Radiation Attenuation, Latex, 6.5

Radiaxon®

FDA UDI

INNOVATIVE HEALTHCARE CORPORATION·10813172025101·Gloves, Radiation Attenuation, Polyisoprene, 7.5

Radiaxon®

FDA UDI

INNOVATIVE HEALTHCARE CORPORATION·10813172025132·Gloves, Radiation Attenuation, Polyisoprene, 9.0

Radiaxon®

FDA UDI

INNOVATIVE HEALTHCARE CORPORATION·10813172025163·Gloves, Radiation Attenuation, Latex, 7.0