KFX KNOTLESS FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

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 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

Aperta NSE PTA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTR

FDA 510(k)

FDA Class 2 ·Cardiovascular

EC50 MICRO+ SMOKERLYZER

FDA 510(k)

FDA Class 2 ·Anesthesiology

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

SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

QUEX ED; QUEX S

FDA 510(k)

FDA Class 2 ·Neurology

Hand-held IPL device (JOVS Hair Removal Device)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Cold Compression Wrap Pro

FDA 510(k)

FDA Class 2 ·Physical Medicine

Hand-held IPL device(JOVS Graphene Hair Removal Device)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery