PFZ PORCELAIN SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ETEST Plazomicin (PLZ) (0.016-256 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB

FDA 510(k)

FDA Class 3 ·Cardiovascular

Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002

FDA 510(k)

FDA Class 2 ·Cardiovascular

SHEATH-IN-SHEATH CATHETER, 18FR, MODEL S00018; SHEATH-IN-SHEATH CATHETER, 6 FR., MODEL S00019

FDA 510(k)

FDA Class 2 ·Cardiovascular

LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM

FDA 510(k)

FDA Class 2 ·Cardiovascular

FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP & ACCE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs

FDA 510(k)

FDA Class 1 ·General Hospital

RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Biodegradable Nitrile Powder Free Examination Glove (Blue)

FDA 510(k)

FDA Class 1 ·General Hospital

IMAGYN LAPAROSCOPIC INSTRUMENTS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff

FDA 510(k)

FDA Class 1 ·General Hospital

Nitrile Powder Free Examination Glove (Blue)

FDA 510(k)

FDA Class 1 ·General Hospital

IMAGYN UROSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IMAGYN FALLOPOSCOPY SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

IMPOWER EXTERNAL VACUUM SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic