Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters

FDA 510(k)

FDA Class 2 ·Orthopedic

MEMO 4D

FDA 510(k)

FDA Class 2 ·Cardiovascular

Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2

FDA 510(k)

FDA Class 2 ·Cardiovascular

CORSINI 9090

FDA 510(k)

FDA Class 2 ·Radiology

Empower H35

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MINIARS SCREWS

FDA 510(k)

FDA Class 2 ·Orthopedic

CARPEDIEM System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SpaceFlex Knee

FDA 510(k)

FDA Class 2 ·Orthopedic

Artiglass NRFitTM Tip L.O.R. Glass Syringes

FDA 510(k)

FDA Class 2 ·General Hospital

AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MTS Ceftobiprole 0.002-32 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

Delta Multihole TT Pro Acetabular System

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO SENTINEL CLIN CHEM CAL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CHROMOTITRE E.I.A. RUBELLA IGG

FDA 510(k)

FDA Class 2 ·Microbiology

INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAIA (AHMACME001)

FDA 510(k)

FDA Class 2 ·Ophthalmic

SPIROTEL

FDA 510(k)

FDA Class 2 ·Anesthesiology

Hang&Go PAC

FDA 510(k)

FDA Class 2 ·General Hospital

FIBER DISK AND BLOCK PERMANENT, TRINIA

FDA 510(k)

FDA Class 2 ·Dental