Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE

FDA 510(k)

FDA Class 2 ·Anesthesiology

Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20

FDA 510(k)

FDA Class 2 ·Anesthesiology

AIMAGO EASYLDI MICROCIRCULATION CAMERA

FDA 510(k)

FDA Class 2 ·Cardiovascular

DUPONT ACA PLUS FSH/LH/PROLACTIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

WHITE ASH - FRAXINUS AMERICANA (T15) ALLERGEN DISC

FDA 510(k)

FDA Class 2 ·Immunology

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Elecsys free PSA, free PSA Calset, free PSA CalCheck

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ELSECSYS FREE PSA IMMUNOASSAY,FREE PSA CALSET,FREE PSA CALCHECK

10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL; 10F X 24CM PEDIATRIC ASH SPLIT-CATH XL, MODEL ASPC24P-XL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS TOTAL PSA IMMUNOASSAY/TOTAL PSA CALSET

14F X 55CM ASH SPLIT-CATH XL, MODEL ASPC55-XL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300

FDA 510(k)

FDA Class 2 ·General Hospital

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·IMMULITE 2500 PSA, IMMULITE 2500 THIRD GENERATION PSA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·IMMULITE/IMMULITE 1000 PSA & 1000 THIRD GENERATION PSA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·AIA-PACK PA PSA, ST AIA-PACK PA PSA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·TANDEM-R PSA & TANDEM-E PSA IMMUNOENZYMETRIC ASSAY

Finapres Nova Noninvasive Hemodynamic Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular