MYALLERGYTEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

NemoScan

FDA 510(k)

FDA Class 2 ·Radiology

VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)

FDA 510(k)

FDA Class 2 ·Microbiology

Osteon Precision Milled Suprastructure

FDA 510(k)

FDA Class 2 ·Dental

VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)

FDA 510(k)

FDA Class 2 ·Microbiology

VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FETAL MONITORING TRANSDUCER STRAP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)

FDA 510(k)

FDA Class 2 ·Microbiology

Osteon Precision Milled Suprastructure

FDA 510(k)

FDA Class 2 ·Dental

EchoGuide (Version 1)

FDA 510(k)

FDA Class 2 ·Radiology

NemoCast

FDA 510(k)

FDA Class 2 ·Dental

VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST

FDA 510(k)

FDA Class 2 ·Microbiology

VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)

FDA 510(k)

FDA Class 2 ·Microbiology

4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SPIROLAB, SPIROLAB II

FDA 510(k)

FDA Class 2 ·Anesthesiology

ILT ADVANCING MECHANISM, MODEL A115AMI

FDA 510(k)

FDA Class 2 ·Cardiovascular

SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT CATHETER 0.14, SAFE CROSS ANGLED SUPPORT CATHETER, SAFE CROT

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPIROBANK II

FDA 510(k)

FDA Class 2 ·Anesthesiology

ENDEARE BREAST PUMP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Smart One

FDA 510(k)

FDA Class 2 ·Anesthesiology