CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SUTURE LOCK NAIL BONE ANCHOR WITH WHITE (KFX-W-200) & BLUE (KFX-B-200) FIBERFORCE SUTURE

FDA 510(k)

FDA Class 2 ·Orthopedic

5.5 MM SUTURE LOCK BONE SCREW ANCHOR

FDA 510(k)

FDA Class 2 ·Orthopedic

KFX TISSUE FIXATION SYSTEM AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Orthopedic

KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE

FDA 510(k)

FDA Class 2 ·Orthopedic

KFX KNOTLESS FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

KFX APPIANFX PEEK FEMORAL IMPLANT WITH INSERTER

FDA 510(k)

FDA Class 2 ·Orthopedic

APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHOR

FDA 510(k)

FDA Class 2 ·Orthopedic

AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KALIX II IMPLANT, MODEL 141 0XX WITH XX

FDA 510(k)

FDA Class 2 ·Orthopedic

STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX

FDA 510(k)

FDA Class 2 ·Orthopedic

BLOOD PRESSURE MONITOR, MODELS ZSBP-OXX AND ZSBP-1XX

FDA 510(k)

FDA Class 2 ·Cardiovascular

Aperta NSE PTA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Cryopush Cold Compression Device

FDA 510(k)

FDA Class 2 ·Physical Medicine

Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Hand-held IPL device (JOVS Hair Removal Device)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Vdrive system, Vdrive Duo, Vdrive with V-Sono

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR

FDA 510(k)

FDA Class 2 ·Cardiovascular