MIS V3 Conical Connection Dental Implant System­

FDA 510(k)

FDA Class 2 ·Dental

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

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

Fuse Endoscopic System with FuseBox Processor

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PRE' VAGINAL LUBRICANT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PENTAX Medical Auto Leakage Tester SHA-P6

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

JO Actively Trying Personal Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Actively Trying Personal Lubricant Rose Scented

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PENTAX Medical EPK-i7010 Video Processor with GI Family

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PRE-VA VAGINAL LUBRICANT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BioGenesis Fertility Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AUTOMATED ENDOSCOPE LEAK TESTER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX EPK-I5010 VIDEO PROCESSOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Actively Trying Personal Lubricant Unfragrance

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Pre-Seed™ Fertility Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

EPX-4440HD DIGITAL VIDEO PROCESSOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PENTAX Medical Video Processor (EPK-i8020c)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CONCEIVE PLUS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology