SONICAID FM820, SONICAID FM830

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SONICAID ONE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SYNERGY LT

FDA 510(k)

FDA Class 2 ·Neurology

DG NERVUS

FDA 510(k)

FDA Class 2 ·Neurology

TECA PREMIERE

FDA 510(k)

FDA Class 2 ·Neurology

DG PORTABLE SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS RX/OTW SOLARIS CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·QUANTUM MAVERICK MONORAIL & OTW PTCA CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NC STORMER MX2/OTW BALLOON DILATATION CATHETER

LOW PROFILE PLASTIC PORT DETACHED CATHETER SYSTEM CATALOG #1017

FDA 510(k)

FDA Class 2 ·General Hospital

BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

EMIT D.A.U. LOW CALIBRATOR A & MEDIUM CALI. A

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology

LOW PROFILE TITANIUM PORT DETACHED CATHETER SYSTEM CATALOG #1037

FDA 510(k)

FDA Class 2 ·General Hospital

THEREX LOW PROFILE TITANIUM MODEL 1.0MM I.D./1.8MM O.D.

FDA 510(k)

FDA Class 2 ·General Hospital

HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High

FDA 510(k)

FDA Class 2 ·Hematology

SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATION

FDA 510(k)

FDA Class 2 ·General Hospital