Data / Medical devices / Germany / Novanta Medical GmbH
Novanta Medical GmbH: FDA-registered device maker in LUDWIGSSTADT Bavaria, Germany, 15 510(k) clearances
Novanta Medical GmbH is registered with the FDA (registration 8043980) in LUDWIGSSTADT Bavaria, Germany. It lists 15 device types. The FDA files 15 510(k) clearances under its listings, the newest dated December 5, 2025. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 8043980
- FEI number
- 3002914049
- Address
- Alte Post STR. 11, LUDWIGSSTADT Bavaria, Germany, D-96337
- Owner or operator
- Novanta Medical GmbH (9004880)
- Roles
- Contract manufacturer, Exporter to the US, 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
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 |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 24, 2024 | 94749 | Class II | Ongoing | WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries. Distr. by Endoscopy Smith & Nephew Inc. REF Numbers: T0449-01 | Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery | accessdata.fda.gov |
| July 17, 2023 | 92938 | Class II | Ongoing | Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowing into and out of t | The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflow volume display will freeze at the maximum value while the deficit will start counting backwards until 0 ml is reached and may result in fluid overload | accessdata.fda.gov |
Compare with other makers
- All makers of Laparoscope, Gynecologic (And Accessories)
- All makers of Insufflator, Hysteroscopic
- All makers of System, Digital Image Communications, Radiological
- All makers of Insufflator, Laparoscopic
- All makers of Insufflator, Endoscopic Vessel Harvesting
- All makers of Laparoscope, General & Plastic Surgery
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.