Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NEPTUNE X-ACT/NEPTUNE X-ACT OTW BALLOON DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK OTW/MAVERICK 2 MONORAIL PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·QUANTUM MAVERICK MONORAIL/OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME CUTTING BALLOON MONORAIL (MR) AND OVER-THE-WIRE (OTW)

ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3

FDA 510(k)

FDA Class 2 ·Cardiovascular

MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER

FDA 510(k)

FDA Class 2 ·Anesthesiology

DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP

FDA 510(k)

FDA Class 2 ·Neurology

PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

THEREX LOW PROFILE B PORT 1.0MM I.D./1.8MM O.D. DETACHED CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital

GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00

FDA 510(k)

FDA Class 2 ·Neurology

Low Dose CT Lung Cancer Screening Option for Qualified GE Systems

FDA 510(k)

FDA Class 2 ·Radiology

METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK

FDA 510(k)

FDA Class 2 ·Hematology

ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203

FDA 510(k)

FDA Class 2 ·Neurology

LIFEPAK® 35 AC Power Adapter (41335-000001)

FDA 510(k)

FDA Class 2 ·Cardiovascular

HIGHPAK-12

FDA 510(k)

FDA Class 2 ·Cardiovascular

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK2 MONORAIL AND MAVERICK OTW PTCA CATHETER, QUANTUM MAVERICK PTCA CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·QUANTUM MAVERICK MONORAIL & OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·APEX MONORAIL & OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) DILATATION CATHETERS