Olympus Medical Products Czech

FDA Filings

This page includes the latest FDA filings for Olympus Medical Products Czech. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3007960282
• FEI Number: 3007960282
• Name: Olympus Medical Products Czech
• Owner & Operator: Olympus Winter & Ibe GmbH
• Contact Address: KUEHNSTRASSE 61 --; HAMBURG DE-NOTA 22045 DE
• US Agent:
  • Troy Quander
  • 508 8044716
  • Troy.quander@olympus-osta.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Ul Telickova 457/29 ; Prerov II Predmosti Prerov, 75124 CZ
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
PMN K172535 | GEI Olympus Medical Products Czech [Olympus Winter & Ibe GmbH]	Bipolar Applicator CELON ProCurve V	2017-11-20
PMN K171965 | HIH Olympus Medical Products Czech [Olympus Winter & Ibe GmbH]	Resection Electrodes With HF Cable	2017-11-01
PMN K171965 | FJL Olympus Medical Products Czech [Olympus Winter & Ibe GmbH]	Resection Electrodes With HF Cable	2017-11-01
PMN K171965 | FAS Olympus Medical Products Czech [Olympus Winter & Ibe GmbH]	Resection Electrodes With HF Cable	2017-11-01
PMN K161600 | JOS Olympus Medical Products Czech [Olympus Winter & Ibe GmbH]	HF-resection electrodes	2016-09-12
PMN K161600 | HIH Olympus Medical Products Czech [Olympus Winter & Ibe GmbH]	HF-resection electrodes	2016-09-12
PMN K032838 | GEI Olympus Medical Products Czech [Olympus Winter & Ibe GmbH]	CELON ENT SYSTEM	2016-09-06
PMN K951863 | FJL Olympus Medical Products Czech [Olympus Winter & Ibe GmbH]	HF Resection electrode, cylinder	2016-02-18
PMN K951863 | FAS Olympus Medical Products Czech [Olympus Winter & Ibe GmbH]	HF Resection electrode, cylinder	2016-02-18
PMN K152092 | HIH Olympus Medical Products Czech [Olympus Winter & Ibe GmbH]	HF Resection Electrodes	2016-02-18
PMN K152092 | FJL Olympus Medical Products Czech [Olympus Winter & Ibe GmbH]	HF Resection Electrodes	2016-02-18
PMN K152092 | FAS Olympus Medical Products Czech [Olympus Winter & Ibe GmbH]	HF Resection Electrodes	2016-02-18
PMN K120418 | GEI Olympus Medical Products Czech [Olympus Winter & Ibe GmbH]	HF Resection Electrodes	2016-02-18
PMN K120418 | FAS Olympus Medical Products Czech [Olympus Winter & Ibe GmbH]	HF Resection Electrodes	2016-02-18
PMN K030194 | KNS Olympus Medical Products Czech [Olympus Winter & Ibe GmbH]	XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT	2016-02-18
PMN K073207 | GEI Olympus Medical Products Czech [Olympus Winter & Ibe GmbH]	ESG-100 and accessories	2011-12-16
PMN K073207 | GEI Olympus Medical Products Czech [Olympus Winter & Ibe GmbH]	AFU-100 and accessories	2011-12-16
PMN K073207 | FEQ Olympus Medical Products Czech [Olympus Winter & Ibe GmbH]	ESG-100 and accessories	2011-12-16
PMN K073207 | FEQ Olympus Medical Products Czech [Olympus Winter & Ibe GmbH]	AFU-100 and accessories	2011-12-16
PMN K102781 | GEI Olympus Medical Products Czech [Olympus Winter & Ibe GmbH]	HF Resection Electrode	2011-06-06
PMN K102781 | FAS Olympus Medical Products Czech [Olympus Winter & Ibe GmbH]	HF Resection Electrode	2011-06-06
PMN K100275 | GEI Olympus Medical Products Czech [Olympus Winter & Ibe GmbH]	HF Resection Electrode	2010-07-12
PMN K100275 | FAS Olympus Medical Products Czech [Olympus Winter & Ibe GmbH]	HF Resection Electrode	2010-07-12
PMN K954488 | HIH Olympus Medical Products Czech [Olympus Winter & Ibe GmbH]	Roller Electrodes for OB/Gyn	2008-06-20
PMN K931764 | HIH Olympus Medical Products Czech [Olympus Winter & Ibe GmbH]	HF Resection Electrode Loop with Runner	2008-06-20
PMN K931763 | FJL Olympus Medical Products Czech [Olympus Winter & Ibe GmbH]	HF Resection Electrode Loop with runner	2008-06-20
PMN K931763 | FAS Olympus Medical Products Czech [Olympus Winter & Ibe GmbH]	HF Resection Electrode Loop with runner	2008-06-20
PMN K904939 | EZO Olympus Medical Products Czech [Olympus Winter & Ibe GmbH]	Flexible and rigid ureterotome system	2007-12-07
PMN K903323 | KNS Olympus Medical Products Czech [Olympus Winter & Ibe GmbH]	Electrosurgical loops	2007-12-07