RIGID TELESCOPES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Chemistry Analyzer Model: ACCENT S120

Device

EU IVDR · Eu Ivd Class A ·PZ CORMAY Spółka Akcyjna·On the market·1 country

Chemistry Analyzer Model: ACCENT S120

Device

EU IVDR · Eu Ivd Class A ·PZ CORMAY Spółka Akcyjna·On the market

CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h > 400 and <= 800)

Device

EU IVDR · Eu Ivd Class A ·PZ CORMAY Spółka Akcyjna·On the market

CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)

Device

EU IVDR · Eu Ivd Class A ·PZ CORMAY Spółka Akcyjna·On the market

CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)

Device

EU IVDR · Eu Ivd Class A ·PZ CORMAY Spółka Akcyjna·On the market

CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)

Device

EU IVDR · Eu Ivd Class A ·PZ CORMAY Spółka Akcyjna·On the market

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

OAC (OPTICAL ASPIRATING CURETTE)

FDA 510(k)

FDA Class 1 ·Obstetrics/Gynecology

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