K-L-W INTRAORAL DISTRACTOR

FDA 510(k)

FDA Class 2 ·Dental

CTF SYSTEMS INC, WHOLE-CORTEX MEG SYSTEM (WITH OPTIONAL EEG SUBSYSTEM)

FDA 510(k)

FDA Class 2 ·Neurology

KLS-MARTIN INTRAORAL DISTRACTOR

FDA 510(k)

FDA Class 2 ·Dental

VASOGENICS EECP-MC2

FDA 510(k)

FDA Class 2 ·Cardiovascular

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

FDA classification

FDA Class 2 ·Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Access PCT

FDA 510(k)

FDA Class 2 ·Microbiology

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set

FDA 510(k)

FDA Class 2 ·Microbiology

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

FDA 510(k)

FDA Class 2 ·Microbiology

Access PCT, Access PCT Calibrators

FDA 510(k)

FDA Class 2 ·Microbiology

NEWDEAL INTERPHALANGEAL IMPLANT

FDA 510(k)

FDA Class 2 ·Orthopedic

Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained

FDA classification

FDA Class 2 ·Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained

Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained

FDA classification

FDA Class 2 ·Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained

Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens

FDA classification

FDA Class 2 ·Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens

Light, Lymphedema Reduction, Low Energy

FDA classification

FDA Class 2 ·Light, Lymphedema Reduction, Low Energy

Antigen, Inflammatory Response Marker, Sepsis

FDA classification

FDA Class 2 ·Antigen, Inflammatory Response Marker, Sepsis

Endoscopic Storage Cover

FDA classification

FDA Class 2 ·Endoscopic Storage Cover

Tubing, Long Term Support Greater Than 6 Hours

FDA classification

FDA Class 2 ·Tubing, Long Term Support Greater Than 6 Hours

Ankle Fusion Cage

FDA classification

FDA Class 2 ·Ankle Fusion Cage

Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer

FDA classification

FDA Class 2 ·Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer