BIOPSY ATTACHMENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003

FDA 510(k)

FDA Class 1 ·Gastroenterology, Urology

BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BT-338N ELECTRONIC CLINICAL THERMOMETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DISPOSABLE, STERILE BIOPSY PUNCH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ANEROID BLOOD PRESSURE GAUGE

FDA 510(k)

FDA Class 1 ·Gastroenterology, Urology

Ritleng®+ and Ritleng®+ PVP

FDA 510(k)

FDA Unclassified ·Unknown

LacriJet®

FDA 510(k)

FDA Unclassified ·Unknown

EZYPOR

FDA 510(k)

FDA Class 2 ·Ophthalmic

Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants

FDA 510(k)

FDA Class 2 ·Ophthalmic

MASTERKA 40 MASTERKA 35 MASTERKA 30

FDA 510(k)

FDA Unclassified ·Unknown

SELF-RETAINING BICANALICULUS INTUBATON SET II

FDA 510(k)

FDA Unclassified ·Unknown

CRAWFORD BIOCANALICULUS INTUBATION

FDA 510(k)

FDA Unclassified ·Unknown

Punch, Biopsy

FDA classification

FDA Class 2 ·Punch, Biopsy

Bulb, Inflation, For Endoscope

FDA classification

FDA Class 1 ·Bulb, Inflation, For Endoscope

France Chirurgie Instrumentation SAS (FCI S.A.S.)

System producer

🇫🇷 France

DCI International, LLC

Manufacturer

🇺🇸 United States·2 Basic UDI-DIs·2 Devices·2 Importers

FBI Medizintechnik GmbH

Manufacturer

🇩🇪 Germany

BCI

FDA registration

ICU Medical, Inc.·1 product·🇺🇸 United States

BCI

FDA registration

ICU Medical, Inc.·1 product·🇺🇸 United States