PCX-100 PATIENT INPUT LEADWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE TESTING

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PCI 4000

FDA 510(k)

FDA Class 2 ·Physical Medicine

PCI 2500

FDA 510(k)

FDA Class 2 ·Physical Medicine

COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

GRAFTCAGE ACX

FDA 510(k)

FDA Class 2 ·Orthopedic

OXYPULSE EOC I, EOC II & EOC R

FDA 510(k)

FDA Class 2 ·Anesthesiology

GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor

FDA 510(k)

FDA Class 2 ·Radiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACX RX COMET VP CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·HARTZLER ACX II(R) CORONARY DILATATION CATHETER

ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump

FDA 510(k)

FDA Class 2 ·General Hospital

AVIA PAIN MEDICATION DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

MEDLEY PCA MODULE, MODEL 8120

FDA 510(k)

FDA Class 2 ·General Hospital

PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

MICROJET CRONO PCA

FDA 510(k)

FDA Class 2 ·General Hospital

CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM)

FDA 510(k)

FDA Class 2 ·General Hospital

ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384

FDA 510(k)

FDA Class 2 ·General Hospital

CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR

FDA 510(k)

FDA Class 2 ·General Hospital

CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital