MACROPOREDX DISTRACTOR SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

Acucy Influenza A&B Test with the Acucy System

FDA 510(k)

FDA Class 2 ·Microbiology

MACROPORENS CRANILOC

FDA 510(k)

FDA Class 2 ·Neurology

MACROPOREMX MANDIBULAR FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

MACROPORE OS TRAUMA

FDA 510(k)

FDA Class 2 ·Orthopedic

PIUR tUS Infinity

FDA 510(k)

FDA Class 2 ·Radiology

INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MACROPORE SURGIWRAP (TS)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MACROPORE IB RESORBABLE PLUG

FDA 510(k)

FDA Class 2 ·Orthopedic

MACROPORE SURGICAL BARRIER FILM

FDA 510(k)

FDA Class 2 ·Ophthalmic

MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MACROPORE HYDROSORB SPINE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MACROPOREPX PEDIATRIC SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

MACROPORE ENT RECONSTRUCTION FILM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MACROPORE OS SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Acucy® Influenza A&B Test with the Acucy® 2 System

FDA 510(k)

FDA Class 2 ·Microbiology

OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test

FDA 510(k)

FDA Class 2 ·Immunology

MACROPORE FX, PS, NS, LP

FDA 510(k)

FDA Class 2 ·Dental

MACROPORE CARDIO-WRAP (TS)

FDA 510(k)

FDA Class 2 ·Cardiovascular

LinkQuest Diagnostic Ultrasound System model SQ860

FDA 510(k)

FDA Class 2 ·Radiology