Over-The-Counter Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·samaritan 350P (SAM350P) Automated External Defibrillator

Over-The-Counter Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·HeartStart OnSite and Home Defibrillator

Over-The-Counter Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·HeartStart OnSite Defibrillator, HeartStart Home Defibrillator and HeartStart FRx Defibrillator

CLEARFIL PHOTO POSTERIOR

FDA 510(k)

FDA Class 2 ·Dental

SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CLEARFIL PORCELAIN BOND

FDA 510(k)

FDA Class 2 ·Dental

CARDIAC STATUS CONTROLS/TROPONIN I

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV

FDA 510(k)

FDA Class 1 ·Microbiology

LUKENS SILK SURGICAL SUTURE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RTX RESPIRATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I)

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV

FDA 510(k)

FDA Class 1 ·Microbiology

BD DIRECTIGEN EZ FLU A + B

FDA 510(k)

FDA Class 2 ·Microbiology

SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TALON SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CARDIAC STATUS CONTROLS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

SpermAlign Sperm Separation Device

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SPINE360 ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

AXIS-SHIELD ACVTIVE-B12

FDA 510(k)

FDA Class 2 ·Clinical Chemistry