Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM SICD GEN 2, SICD EMBLEM MRI , Subcutaneous Implantable Cardioverter Defibrillator (SICD)

NA

FDA UDI

Nucletron B.V.·08717213036611·Flexitron Adapter for 5F Catheters

NA

FDA UDI

Nucletron B.V.·08717213016927·Cleaning Brush Set Ø 2.5 mm x 250 mm

NA

FDA UDI

Nucletron B.V.·08717213007147·Sterilizing Cap Set, 1.9mm

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEN 2 S-ICD & SQ-RX PULSE GENERATOR, SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFRILLATOR

ACE BUN/Urea Reagent

FDA registration

ALFA WASSERMANN·4 products·🇺🇸 United States

ACE CK Reagent

FDA registration

ALFA WASSERMANN·4 products·🇺🇸 United States

EVERON

FDA 510(k)

FDA Class 2 ·Anesthesiology

MICROSCOPE SYSTEM

FDA 510(k)

FDA Class 1 ·Dental

FUJIFILM Endoscope Model EG-530N

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AISAP Cardio V1.0

FDA 510(k)

FDA Class 2 ·Radiology

FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FUJIFILM Endoscopic CO2 Regulator GW-100

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FUJIFILM Endoscope Models EC-600HL and EC-600LS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HM70 EVO Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

FUJIFILM Endoscope Model EB-710P

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

FUJIFILM Ultrasonic Endoscope EG-740UT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Endoscope Model EG-580UT and Endoscope Model EG-580UR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology