Camera, Ophthalmic, General-Use

FDA classification

FDA Class 2 ·Camera, Ophthalmic, General-Use

PFZ PORCELAIN SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

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

FDA 510(k)

FDA Class 2 ·Microbiology

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

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

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMAGYN LAPAROSCOPIC INSTRUMENTS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

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

IMAGYN MICROLAP(TM) LAPAROSCOPE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

IMAGYN HYSTEROSCOPE SHEATHS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

IMAGYN MICROLAP INTRODUCER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GLB BENECHECK PREMIUM GLU MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMAGYN HYSTEROSCOPE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology