mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM)

FDA 510(k)

FDA Class 2 ·Immunology

mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DANTEC ELECTRODES MODEL DNE 116, 117 & 13P02/12

FDA 510(k)

FDA Class 2 ·Physical Medicine

SYMETREX LONG TERM HEMODIALYSIS CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN COLOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SIMPLER MINI IMPLANT, MODELS SM 5002, SM 5003, SM 5004

FDA 510(k)

FDA Class 2 ·Dental

TRUSTEX CHOCOLATE FLAVORED CONDOM IN BLACK COLOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BONAMATES SERIES

FDA 510(k)

FDA Class 2 ·Dental

FLOWTRON EXCEL PUMP

FDA 510(k)

FDA Class 2 ·Cardiovascular

ONE STICK Y EXTENSION SET AND VOLUMETER

FDA 510(k)

FDA Class 2 ·General Hospital

VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Xultan 5.5 Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

AUDERE Lumbar Spacer System

FDA 510(k)

FDA Class 2 ·Orthopedic

Met One Czar Anterior Cervical Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

TRUSTEX COLA FLAVORD CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE COLOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology