SYNTHECEL DURA REPLACEMENT DEVICES

FDA 510(k)

FDA Class 2 ·Neurology

BIO-CHEM ANALYZER, MODEL 100

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Aspire Introducer Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Sirona Dental CAD/CAM System

FDA 510(k)

FDA Class 2 ·Dental

SYNTHES PILON PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

THERAPORT VASCULAR ACCESS SYSTEM; MODEL 1001, 1002, 1601, 1602

FDA 510(k)

FDA Class 2 ·General Hospital

GRIESHABER GLOBAL CONTROL TUBING SET

FDA 510(k)

FDA Class 2 ·Ophthalmic

PLEATMAN SAC SPECIMEN CONTAINER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Trilogy Evo

FDA 510(k)

FDA Class 2 ·Anesthesiology

BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

STAIR SYSTEMS PACS & DICOM VIEWER

FDA 510(k)

FDA Class 2 ·Radiology

DS Implants abutments provided with the EV connection

FDA 510(k)

FDA Class 2 ·Dental

ELECTRO-TOUCH (ET) GLOVE

FDA 510(k)

FDA Class 2 ·Neurology

TWO SKIN TREATMENT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK, MODELS PD100.12 AND PD100.13

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INDEPENDENCE SPACER

FDA 510(k)

FDA Class 2 ·Orthopedic

SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer

FDA 510(k)

FDA Class 2 ·Orthopedic

DePuy Synthes Femoral Recon Nail System

FDA 510(k)

FDA Class 2 ·Orthopedic

DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery