VERSAPORT BLADELESS LOW PROFILE TROCAR MODEL NB3SHFLP, NB5SHFLP, NB5STFLP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

RINSE & REFERENCE SOLUTION/BUFFER/LOW & HIGH STAN.

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

4 LOW VOLUME IV EXTENSION SET WITH SLIDE CLAMP

FDA 510(k)

FDA Class 2 ·General Hospital

SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DV

FDA 510(k)

FDA Class 2 ·Cardiovascular

PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

MODEL #716 ADULT STIM. PADS LOW IMPEDANCE GEL TYPE

FDA 510(k)

FDA Class 2 ·Cardiovascular

LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL

FDA 510(k)

FDA Class 2 ·Dental

SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High

FDA 510(k)

FDA Class 2 ·Hematology

VERSYS FIBER METAL MIDCOAT LOW HEAD CENTER HIP PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·QUANTUM MAVERICK PTCA CATHETER/MAVERICK OTW PTCA CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK2 MONORAIL & MAVERICK OTW PTCA DILATATION CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK 2 MONORAIL AND MAVERICK OTW PTCA CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·BSC APEX MONORAIL & OTW PTCA DILATATION CATHETERS

Catheter, Angioplasty, Peripheral, Transluminal

FDA Pre-Market Approval

FDA Class 2 ·CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)

PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTRODUCER SET, PORT-A

FDA 510(k)

FDA Class 2 ·General Hospital

THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012

FDA 510(k)

FDA Class 2 ·General Hospital

GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL

FDA 510(k)

FDA Class 2 ·Hematology