CapSure® PS System

FDA 510(k)

FDA Class 2 ·Orthopedic

BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT

FDA 510(k)

FDA Class 2 ·Microbiology

Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200

FDA 510(k)

FDA Class 2 ·Cardiovascular

RSA-CMS

FDA 510(k)

FDA Class 2 ·Radiology

POWERPORT IMPLANTABLE PORT

FDA 510(k)

FDA Class 2 ·General Hospital

SculpSure

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy Wearable Breast Pump (BP324); Momcozy Wearable Breast Pump (BP334); Momcozy Wearable Breast Pump (BP430)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU

FDA 510(k)

FDA Class 2 ·General Hospital

RINSE MACHINE KR-4 KIDNEY RINSE-4

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Pantheon Proximal Femur Reconstruction (PFR) System

FDA 510(k)

FDA Class 2 ·Orthopedic

Cystatin C

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Manual Antimicrobial Susceptibility Test Systems

FDA Pre-Market Approval

FDA Class 2 ·UNISCEPT(TM)

Manual Antimicrobial Susceptibility Test Systems

FDA Pre-Market Approval

FDA Class 2 ·UNISCEPT(TM)

DAYLITE XENON LIGHT SOURCES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CANNULATED SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CODMAN ANTERIOR CERVICAL SPINE PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Q2 Low Pressure Power Injection Extension Set

FDA 510(k)

FDA Class 2 ·General Hospital

XSTAT-12, 3-Pack, XSTAT-12, 1-Pack

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

3M TEMPORARY CROWN & BRIDGE MATERIAL

FDA 510(k)

FDA Class 2 ·Dental

APEX SPINE SYSTEM W/ COCR RODS

FDA 510(k)

FDA Class 2 ·Orthopedic