DADE IAC-X COMPREHENSIVE IMMUNOASSAY CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Infinity Acute Care System (IACS) Monitoring System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Infinity Acute Care System (IACS) Monitoring Solution

FDA 510(k)

FDA Class 2 ·Cardiovascular

INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION

FDA 510(k)

FDA Class 2 ·Cardiovascular

ELASTIC STAIN

FDA 510(k)

FDA Class 1 ·Hematology

KINAMED REALITY TOTAL HIP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

KINAMED ATH-POROUS AND ATH-POROUS LONG TOTAL HIP

FDA 510(k)

FDA Class 2 ·Orthopedic

Vertex Hip Fracture Nailing System

FDA 510(k)

FDA Class 2 ·Orthopedic

Solo+ Tympanostomy Tube Device (TTD)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AUTONEB ACCESSORY CROSS (AAC)

FDA 510(k)

FDA Class 2 ·Anesthesiology

SENSUA!

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AWARE PAD

FDA 510(k)

FDA Class 2 ·Radiology

CORELEADER COLLA-ALGI FIBER MODEL CAW

FDA 510(k)

FDA Unclassified ·Unknown

CORELEADER SCAR-DIMMER

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050

FDA 510(k)

FDA Unclassified ·Unknown

CORELEADER ALGIPLASTER MODEL AP 050501

FDA 510(k)

FDA Unclassified ·Unknown

CORELEADER HEMO-PAD MODEL CPII 02030

FDA 510(k)

FDA Unclassified ·Unknown

CORELEADER COLLA-PAD MODEL CS 03030

FDA 510(k)

FDA Unclassified ·Unknown

OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology