Novanta Medical GmbH
Berlin, DE
Novanta Medical GmbH appears in FDA device records in Berlin, DE. FDA records list 41 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Novanta Medical GmbH carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- W.O.M. World of Medicine GmbH510(k), enforcement report, recall
510(k) clearance history
FDA records hold 41 510(k) clearances for Novanta Medical GmbH between 1992 and 2025. The busiest year on record is 2003, with 5. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 1 |
| 1994 | 2 |
| 1995 | 4 |
| 1996 | 2 |
| 1997 | 1 |
| 1998 | 2 |
| 1999 | 3 |
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 2 |
| 2003 | 5 |
| 2004 | 3 |
| 2006 | 2 |
| 2007 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 3 |
| 2020 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250795 | PUREVUE™ FMS | HRX | Substantially Equivalent | |
| K201361 | PNEUMOCLEAR | HIF | Substantially Equivalent | |
| K173311 | ARTHRO-Pump PA304 | HRX | Substantially Equivalent | |
| K173489 | GYN-Pump PH304 | HIG | Substantially Equivalent | |
| K172040 | Aquilex Fluid Control System AQL-100S | HIG | Substantially Equivalent | |
| K170784 | PNEUMOCLEAR | HIF | Substantially Equivalent | |
| K163320 | LAP-Pump PP110 | HET | Substantially Equivalent | |
| K153513 | Insufflator 50L FM134 | HIF | Substantially Equivalent | |
| K152109 | HD-Camera HDC1000 | FET | Substantially Equivalent | |
| K123732 | HYSTEROSCOPY PUMP HM6 | HIG | Substantially Equivalent | |
| K112642 | AQUILEX FLUID CONTROL SYSTEM H112 | HIG | Substantially Equivalent | |
| K063367 | 45L CORE INSUFFLATOR, MODEL F114 | HIF | Substantially Equivalent | |
| K062380 | FLOSIMPLE ARTHROSCOPY PUMP A120 | HRX | Substantially Equivalent | |
| K060723 | 40 L HIGH FLOW INSUFFLATOR F113 | HIF | Substantially Equivalent | |
| K042457 | URO PRO | LJH | Substantially Equivalent | |
| K030837 | 40 L HIGH FLOW INSUFFLATOR F108 | HIF | Substantially Equivalent | |
| K033927 | ARTHOSCOPY PUMP A115 | HRX | Substantially Equivalent | |
| K032023 | W.O.M. LASER U100PLUS | GEX | Substantially Equivalent | |
| K022721 | UROPOWER | EXY | Substantially Equivalent | |
| K031616 | IUR FLUID MANAGEMENT SYSTEM | HIG | Substantially Equivalent | |
| K030402 | ARTHROSCOPY PUMP, MODEL A107 | HRX | Substantially Equivalent | |
| K022449 | HYSTEREOSCOPY PUMP HM4 | HIG | Substantially Equivalent | |
| K023041 | W.O.M. LASER U100 | GEX | Substantially Equivalent | |
| K021686 | LASER FIBER GF500 | GEX | Substantially Equivalent | |
| K011175 | W.O.M. LASER U100 | GEX | Substantially Equivalent | |
| K000153 | ARTHRO-SURGIMAT-A103 | HRX | Substantially Equivalent | |
| K990732 | LAP-WAVE 3000 (P07) | HET | Substantially Equivalent | |
| K990443 | ARTHRO-SURGIMAT-2000 ECU | HRX | Substantially Equivalent | |
| K983889 | HYS-SURGIFLATOR 150P | HIG | Substantially Equivalent | |
| K983910 | ARTHRO-SURGIMAT-1500 | HRX | Substantially Equivalent | |
| K981859 | SURGIFLATOR-20 ECU | HIF | Substantially Equivalent | |
| K973432 | SURGIFLATOR-30 | HIF | Substantially Equivalent | |
| K955791 | SURGIFLATOR-20 PIM | HIF | Substantially Equivalent | |
| K962114 | ARTHRO-SURGIMAT | HRX | Substantially Equivalent | |
| K954470 | SURGIMOTOR | GEY | Substantially Equivalent | |
| K934866 | HYS-SURGIMAT | HIG | Substantially Equivalent | |
| K933847 | HYS-SURGIFLATOR VP | HIG | Substantially Equivalent | |
| K924523 | HYS-SURGIFLATOR | HIG | Substantially Equivalent | |
| K926259 | SURGIMAT | HET | Substantially Equivalent | |
| K935763 | SURGIPUMP | DQI | Substantially Equivalent | |
| K921264 | SURGIFLATOR | HIF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3001556604 | 3001556604 | Novanta Medical GmbH | Siemensdamm 58, BERLIN 13627 DE | 2026 | and 1 more, listed in full below |
| 8043980 | 3002914049 | Novanta Medical GmbH | ALTE POST STR. 11, LUDWIGSSTADT Bavaria D-96337 DE | 2026 | and 5 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FEMAccessories, Photographic, For Endoscope (Exclude Light Sources)
- HRXArthroscope
- KQMCamera, Surgical And Accessories
- MMPCover, Barrier, Protective
- LMBDevice, Digital Image Storage, Radiological
- FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
- FEIInstrument, Special Lens, For Endoscope
- OSVInsufflator, Endoscopic Vessel Harvesting
- HIGInsufflator, Hysteroscopic
- HIFInsufflator, Laparoscopic
- GCJLaparoscope, General & Plastic Surgery
- HETLaparoscope, Gynecologic (And Accessories)
- GEYMotor, Surgical Instrument, Ac-Powered
- GEXPowered Laser Surgical Instrument
- IZDProbe, Uptake, Nuclear
- LMDSystem, Digital Image Communications, Radiological
- LJHSystem, Irrigation, Urological
- NKCTubing/Tubing With Filter, Insufflation, Laparoscopic
- EXYUroflowmeter
- DQIWithdrawal/Infusion Pump
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2243-2024 | 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 | Class II | Open, Classified | |
| Z-2629-2023 | 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 the uterus. Models AQL-100PBS and AQL-100P | 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 | Class II | Open, Classified | |
| Z-2561-2021 | Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000 | When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system control unit display will freeze because the internal software calculation threshold is reached. The outflow measurement will continue, and so the deficit accumulated up to this point will start counting backwards to 0 ml. There is a risk of distention fluid reaching the soft tissue circulatory system. | Class II | Open, Classified | |
| Z-2767-2019 | Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies. | The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk. | Class II | Terminated | |
| Z-0508-2019 | PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile tube set used in combination with the PNEUMOCLEAR C02 insufflator as a separate accessory. The device PNEUMOCLEAR is a C02 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard, High Flow/Bariatric, Pediatric and Advanced Flow operating mode of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is indicated for pediatric laparoscopic procedures. The Vessel Harvest operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery. The TAMIS operating mode is indicated to fill and distend the rectum and colon using C02 gas during trans anal minimal invasive surgery. | It is possible that the packaging of the product can be damaged by the prongs on the tube set. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain