CRYSTAL FOCUS EMERALD LASER SLT MCX 1.5 CONVEX PRO

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

FDA 510(k)

FDA Class 2 ·General Hospital

GRAFTCAGE ACX

FDA 510(k)

FDA Class 2 ·Orthopedic

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

OPTI-MAX EXTERNALLY THREADED CYLINDRICAL INTERNAL BORE DENTAL IMPLANT, WITH HEALING SCREW

FDA 510(k)

FDA Class 2 ·Dental

OPTI-MAX BODY DIAMETER W/5MM TOP W/EXTERNAL HEX, EXTERNALLY THREADED DENTAL IMPLANT COARSE THREADS

FDA 510(k)

FDA Class 2 ·Dental

OPTI-MAX ANGLED CROWN POST FOR EXTERNALLY-HEXED IMPLANTS, IN 15 DEGREE AND 25 DEGREE INCLINATIONS. FOR IMPLANTS 3.3MM, 4

FDA 510(k)

FDA Class 2 ·Dental

Nautilus VF ECMO Oxygenator

FDA 510(k)

FDA Class 2 ·Cardiovascular

MC3 Crescent Jugular Dual Lumen Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Nautilus Smart ECMO Module

FDA 510(k)

FDA Class 2 ·Cardiovascular

OPTI-MAX EXTERNALLY THREADED EXTERNAL-HEX DENTAL IMPLANT, TITANIUM PLASMA-SPRAY COATED, WITH HEALING SCREW

FDA 510(k)

FDA Class 2 ·Dental

OPTI-MAX PRESS-FIT EXTERNAL-HEX DENTAL

FDA 510(k)

FDA Class 2 ·Dental

MC3 Vascular Access Kit 21030

FDA 510(k)

FDA Class 2 ·Cardiovascular

MC3 QuickFlow Dual Lumen Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

MC3 Jugular Dual Lumen Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

OPTI-MAX INTERNAL-HEX ANGLED IMPLANT CROWN POST, 10 DEGREE & 20 DEGREE INCLINATIONS

FDA 510(k)

FDA Class 2 ·Dental

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS HARTZLER ACX II CORONARY DILATATION BALLOON CA

PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SmartDrive Wheelchair Power Assist

FDA 510(k)

FDA Class 2 ·Physical Medicine