BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD

FDA 510(k)

FDA Class 2 ·Orthopedic

OsteoBridge™ IDSF System

FDA 510(k)

FDA Class 2 ·Orthopedic

LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0

FDA 510(k)

FDA Class 2 ·Orthopedic

PROTOE ENDOSORB SMALL HAMMER TOE PIN

FDA 510(k)

FDA Class 2 ·Orthopedic

PediatrOS RigidTack/FlexTack

FDA 510(k)

FDA Class 2 ·Orthopedic

METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT

FDA 510(k)

FDA Class 2 ·Orthopedic

TWISTCUT ENDOSORB SCREWS

FDA 510(k)

FDA Class 2 ·Orthopedic

MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws

FDA 510(k)

FDA Class 2 ·Orthopedic

OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System

FDA 510(k)

FDA Class 2 ·Orthopedic

ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OSLEOBRIDGE IDSF SPACER CONECTOR

FDA 510(k)

FDA Class 2 ·Orthopedic

OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR

FDA 510(k)

FDA Class 2 ·Orthopedic

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls

FDA 510(k)

FDA Class 2 ·Microbiology

INTRABLOCK BIOBALL HIP SYSTEM (IBS)

FDA 510(k)

FDA Class 2 ·Orthopedic

MECRON Cannulated Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

Pro-X1™ Trochanteric Nailing System

FDA 510(k)

FDA Class 2 ·Orthopedic

Bolt Intravascular Lithotripsy (IVL) System

FDA 510(k)

FDA Class 2 ·Cardiovascular

X-BOLT Hip Fracture Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

TEMPORARY PACEMAKER ELECTRODE

FDA 510(k)

FDA Class 2 ·Cardiovascular