PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BabyDance Fertility Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MODEL 402P SEQUENCER FOR EMPI TEMS DEV

FDA 510(k)

FDA Class 2 ·Neurology

MAGNETIC RESONANCE DIAG. DEV. SPECIAL PURPOSE COIL

FDA 510(k)

FDA Class 2 ·Radiology

CAPD ULTRAVIOLET(U.V.) GERMICIDAL EXCHANGE DEV SYS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY ASPIR. DEV

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DYNAMESH -CICAT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

P-S MEDICAL CSF ACCESS DEV 15MM/25MM

FDA 510(k)

FDA Class 2 ·Neurology

BCD PLUS BLOOD CARDIOPLEGIA SYS(HEREAF REFER DEV)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CONTIMED II BIOFEEDBACK DEV TREAT OF URIN INCONTI

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) SILK(TM)/AGIL(TM) BALL.DIL.CATH. W/PRO/PEL

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) SILK(TM)/AGIL(TM) BALL.DIL.CATH. W/PRO/PEL

SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit

FDA 510(k)

FDA Class 2 ·Neurology

Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit

FDA 510(k)

FDA Class 2 ·Neurology

First Relief

FDA 510(k)

FDA Class 2 ·Neurology

Primary Relief

FDA 510(k)

FDA Class 2 ·Neurology

SPRINT Peripheral Nerve Stimulation (PNS) System

FDA 510(k)

FDA Class 2 ·Neurology

VERTIS PNT CONTROL UNIT, MODEL CU 100; VERTIS PNT SAFEGUIDE-CERVICAL, MODEL SG 102-XXX

FDA 510(k)

FDA Class 2 ·Neurology

DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology