ePlex Respiratory Pathogen Panel

FDA 510(k)

FDA Class 2 ·Microbiology

STRAUMANN DENTAL ABUTMENTS

FDA 510(k)

FDA Class 2 ·Dental

Disposable Temperature Probe

FDA 510(k)

FDA Class 2 ·General Hospital

MLI INTERFERENCE SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

STRAUMANN WN CARES TITANIUM ABUTMENT

FDA 510(k)

FDA Class 2 ·Dental

CARDIAC COOLING JACKET, 8 CM, MODEL CJ-420

FDA 510(k)

FDA Class 2 ·Cardiovascular

SyncVision System

FDA 510(k)

FDA Class 2 ·Radiology

GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ

FDA 510(k)

FDA Class 2 ·Radiology

HOLOGIC MODELS BLK-1, DPA/QDR-1 & QCT-1

FDA 510(k)

FDA Class 2 ·Radiology

FFR V2.5

FDA 510(k)

FDA Class 2 ·Radiology

WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLIP GUN WITH RANEY TYPE SCALP CLIPS

FDA 510(k)

FDA Class 2 ·Neurology

APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720

FDA 510(k)

FDA Class 2 ·Anesthesiology

Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0)

FDA 510(k)

FDA Class 2 ·Neurology

LANX FUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

APEX MEDICAL DIGITAL TENS TS1211, TS1212

FDA 510(k)

FDA Class 2 ·Neurology

APEX MEDICAL DIGITAL EMS TS1311, TS1312

FDA 510(k)

FDA Class 2 ·Physical Medicine

BLACKSTONE SPINAL FIXATION SYSTEM SPACER

FDA 510(k)

FDA Class 2 ·Orthopedic

Electric Wheelchair (LW01301A07)

FDA 510(k)

FDA Class 2 ·Physical Medicine

VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION FOR INTEGRATED SYSTEM,VOLCANO S5 PRECISION

FDA 510(k)

FDA Class 2 ·Radiology