HLE-1000 HIGH/LOW TREATMENT TABLE

FDA 510(k)

FDA Class 1 ·Physical Medicine

ALES

FDA 510(k)

FDA Class 1 ·Ophthalmic

Second Opinion® BLE

FDA 510(k)

FDA Class 2 ·Radiology

BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACTIVATOR V SPINAL ADJUSTING INSTRUMENT

FDA 510(k)

FDA Unclassified ·Unknown

FRYE ADJUSTING INSTRUMENT

FDA 510(k)

FDA Unclassified ·Unknown

KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC

FDA 510(k)

FDA Class 1 ·Dental

TRAJECTORY GUIDE, MODEL # TGX-XXX

FDA 510(k)

FDA Class 2 ·Neurology

ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MDT2 BLE Self-Monitoring Blood Glucose System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SYREX SYRINGE

FDA 510(k)

FDA Class 2 ·Dental

CLEARVIEWHD

FDA 510(k)

FDA Class 2 ·Radiology

ClearView cCAD

FDA 510(k)

FDA Class 2 ·Radiology

HALE SUN SURGICAL TOWEL OR O.R. TOWEL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)

FDA 510(k)

FDA Class 2 ·General Hospital

CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

Flap Fixator, Burr Hole Cover

FDA 510(k)

FDA Class 2 ·Neurology

AESCULAP PEEK CRANIOFIX

FDA 510(k)

FDA Class 2 ·Neurology

Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover

FDA 510(k)

FDA Class 2 ·Neurology