Data / Medical devices / Czechia / Novanta Medical S.R.O.

Novanta Medical S.R.O.: FDA-registered device maker in Prelouc Pardubicky Kraj, Czechia, 15 510(k) clearances

Name: Novanta Medical S.R.O. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Novanta Medical S.R.O. is registered with the FDA (registration 3033043422) in Prelouc Pardubicky Kraj, Czechia. It lists 15 device types. The FDA files 15 510(k) clearances under its listings, the newest dated December 5, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3033043422
Address: Pardubicka 1571, Prelouc Pardubicky Kraj, Czechia, 535 01
Owner or operator: Novanta Medical GmbH (9004880)
Roles: Contract manufacturer, Manufacturer
First device listed: April 7, 2004
Registered through: 2026
Brand names listed: 1031 Sterile Sleeve, GAMAA FINDER III, 2222 Hystero Pump II, 40 L High Flow Insufflator F108, F107, F104 and F112, 45L Core Insufflator F114, AQUILEX FLUID CONTROL SYSTEM AQL-100S, AirSeal iFS System, Arthroscopy Pump A107 and A114, Autoclavable Fixed Focal Lenght Coupler and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Photographic, For Endoscope (Exclude Light Sources)	FEM	1	Manufacturer	accessdata.fda.gov
Arthroscope	HRX	2	Manufacturer	accessdata.fda.gov
Camera, Surgical And Accessories	KQM	1	Manufacturer	accessdata.fda.gov
Cover, Barrier, Protective	MMP	2	Manufacturer	accessdata.fda.gov
Device, Digital Image Storage, Radiological	LMB	1	Manufacturer	accessdata.fda.gov
Instrument, Special Lens, For Endoscope	FEI	1	Manufacturer	accessdata.fda.gov
Insufflator, Endoscopic Vessel Harvesting	OSV	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Insufflator, Hysteroscopic	HIG	2	Manufacturer	accessdata.fda.gov
Insufflator, Laparoscopic	HIF	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Contract manufacturer	accessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)	HET	2	Manufacturer	accessdata.fda.gov
Probe, Uptake, Nuclear	IZD	1	Manufacturer	accessdata.fda.gov
System, Digital Image Communications, Radiological	LMD	1	Manufacturer	accessdata.fda.gov
System, Surgical, Computer Controlled Instrument	NAY	2	Contract manufacturer	accessdata.fda.gov
Tubing/Tubing With Filter, Insufflation, Laparoscopic	NKC	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 5, 2025	K250795	PUREVUE FMS	HRX	Substantially Equivalent	W.O.M. World of Medicine GmbH	accessdata.fda.gov
July 29, 2020	K201361	PNEUMOCLEAR	HIF	Substantially Equivalent	W.O.M. World of Medicine GmbH	accessdata.fda.gov
March 28, 2018	K173489	GYN-Pump PH304	HIG	Substantially Equivalent	W.O.M. World of Medicine GmbH	accessdata.fda.gov
February 5, 2018	K172040	Aquilex Fluid Control System AQL-100S	HIG	Substantially Equivalent	W.O.M. World of Medicine GmbH	accessdata.fda.gov
March 21, 2017	K163320	LAP-Pump PP110	HET	Substantially Equivalent	W.O.M. World of Medicine GmbH	accessdata.fda.gov
March 4, 2016	K153513	Insufflator 50L FM134	HIF	Substantially Equivalent	W.O.M. World of Medicine GmbH	accessdata.fda.gov
April 4, 2013	K123732	HYSTEROSCOPY PUMP HM6	HIG	Substantially Equivalent	W.O.M. World of Medicine AG	accessdata.fda.gov
May 23, 2007	K063367	45L CORE INSUFFLATOR, MODEL F114	HIF	Substantially Equivalent	W.O.M. World of Medicine AG	accessdata.fda.gov
December 14, 2006	K062380	FLOSIMPLE ARTHROSCOPY PUMP A120	HRX	Substantially Equivalent	W.O.M. World of Medicine AG	accessdata.fda.gov
February 5, 2004	K030837	40 L HIGH FLOW INSUFFLATOR F108	HIF	Substantially Equivalent	W.O.M. World of Medicine AG	accessdata.fda.gov
August 13, 2003	K031616	IUR FLUID MANAGEMENT SYSTEM	HIG	Substantially Equivalent	W.O.M. World of Medicine AG	accessdata.fda.gov
April 17, 2003	K030402	ARTHROSCOPY PUMP, MODEL A107	HRX	Substantially Equivalent	W.O.M. World of Medicine AG	accessdata.fda.gov
April 10, 2003	K022449	HYSTEREOSCOPY PUMP HM4	HIG	Substantially Equivalent	W.O.M. World of Medicine AG	accessdata.fda.gov
July 23, 1999	K990732	LAP-WAVE 3000 (P07)	HET	Substantially Equivalent	W.O.M. World of Medicine GmbH	accessdata.fda.gov
September 22, 1997	K970885	ULTRASOUND SYSTEMS DRAPE	MMP	Substantially Equivalent	Protek Medical Products, Inc.	accessdata.fda.gov

Compare with other makers

Updated December 5, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.