INFINITECH OTOPROBE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

INFRAGUIDE(TM)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

END-IRRIGATING ENDOILLUMINATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODEL 4070 TEMPERATURE MONITOR

FDA 510(k)

FDA Class 2 ·General Hospital

TRU-STIM MUSCLE STIMULATOR

FDA 510(k)

FDA Class 2 ·Physical Medicine

DISPOSABLE IRRIGATING/ASPIRATING HANDPIECE

FDA 510(k)

FDA Class 2 ·Ophthalmic

INFINITECH LIGHTED INFUSION CANNULA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SYNTHES PATIENT SPECIFIC PLATE

FDA 510(k)

FDA Class 2 ·Dental

INFINITECH HIGH INTENSITY XENON LIGHT SOURCE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ULTRASPOT MICROMANIPULATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BARE-FIBER ENDOILLUMINATOR

FDA 510(k)

FDA Class 2 ·Ophthalmic

INFINITECH SOFT TIP FLUTE NEEDLE

FDA 510(k)

FDA Class 2 ·Ophthalmic

SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NC MONORAIL PTC CATHETER, QUANTUM MONORAIL PTCA CATHETER, MAXXUM PTCA CATHETER, VIVA PTCA CATHETER AND ADANTE PTCA CATHR

Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set

FDA 510(k)

FDA Class 2 ·General Hospital