Dornier Medtech America, Inc.
Kennesaw, GA, US
DORNIER MEDTECH AMERICA, INC. appears in FDA device records in Kennesaw, GA. FDA records list 46 510(k) clearances between and , 69 PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 46 510(k) clearances for Dornier Medtech America, Inc. between 1990 and 2025. The busiest year on record is 2013, with 4. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 2 |
| 1991 | 1 |
| 1993 | 1 |
| 1995 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 2001 | 2 |
| 2002 | 3 |
| 2006 | 1 |
| 2007 | 2 |
| 2008 | 2 |
| 2009 | 2 |
| 2011 | 1 |
| 2012 | 3 |
| 2013 | 4 |
| 2014 | 1 |
| 2015 | 3 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 3 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243820 | Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250 | FED | Substantially Equivalent | |
| K233380 | TRIDENT Mobile Fluoroscopy System | JAA | Substantially Equivalent | |
| K221903 | Delta III Pro | LNS | Substantially Equivalent | |
| K213252 | Dornier Thulio | GEX | Substantially Equivalent | |
| K220871 | Nautilus | JAA | Substantially Equivalent | |
| K210394 | Electrosurgical accessory | FAS | Substantially Equivalent | |
| K201815 | Dornier MAGELLAN Ureteral Access Sheath | FED | Substantially Equivalent | |
| K201074 | Delta III Lithotripter | LNS | Substantially Equivalent | |
| K190612 | EQUINOX Balloon Dilatation Catheter | EZN | Substantially Equivalent | |
| K190312 | Dornier Ureteral Stent | FAD | Substantially Equivalent | |
| K191187 | Dornier MINNOW Ureteral Catheter | EYB | Substantially Equivalent | |
| K180350 | Dornier Medilas H Solvo 35 Laser | GEX | Substantially Equivalent | |
| K172084 | Delta III Lithotripter | LNS | Substantially Equivalent | |
| K170122 | Delta III Lithotripter | LNS | Substantially Equivalent | |
| K161771 | Medilas H Laser Fibers | GEX | Substantially Equivalent | |
| K152591 | Medilas H RFID Laser Fibers | GEX | Substantially Equivalent | |
| K151298 | Gemini XXP-HP | LNS | Substantially Equivalent | |
| K151485 | GENESIS | JAA | Substantially Equivalent | |
| K133434 | GENESIS II | JAA | Substantially Equivalent | |
| K132672 | EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER | LNS | Substantially Equivalent | |
| K130344 | DORNIER MEDILAS UROPULSE | GEX | Substantially Equivalent | |
| K122159 | DORNIER MEDILAS H30 SOLVO | GEX | Substantially Equivalent | |
| K122768 | GENESIS | JAA | Substantially Equivalent | |
| K123385 | MEDILAS H LASER FIBERS | GEX | Substantially Equivalent | |
| K121656 | GEMINI LITHOTRIPTER | LNS | Substantially Equivalent | |
| K121938 | MEDILAS H RFID LASER FIBER | GEX | Substantially Equivalent | |
| K110364 | DORNIER MEDILAS D LITEBEAM+ 1470 | GEX | Substantially Equivalent | |
| K083500 | MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE | GEX | Substantially Equivalent | |
| K083258 | MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE | GEX | Substantially Equivalent | |
| K073427 | MEDILAS D FAMILY LASERS | GEX | Substantially Equivalent | |
| K080959 | DORNIER MEDILAS D 30 LASER, MEDILAS D 1064 | GEX | Substantially Equivalent | |
| K070536 | MEDILAS D FAMILY LASERS | GEX | Substantially Equivalent | |
| K070123 | TCA 5R / 5S | OWB | Substantially Equivalent | |
| K061455 | DORNIER MEDILAS H 20 LASER | GEX | Substantially Equivalent | |
| K020339 | DORNIER DIODE LASER FAMILY MEDILAS D, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEM | GEX | Substantially Equivalent | |
| K022544 | DORNIER MEDILAS H LASER FIBER CABLES | GEX | Substantially Equivalent | |
| K021724 | DORNIER DIODE LASER FAMILY, INCLUDING MEDILAS D FIBERTOM, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEMS | GEX | Substantially Equivalent | |
| K011322 | DORNIER SAPPHIREERBIUM HANDPIECE, DORNIER SAPPHIRESPOT HANDPIECE | GEX | Substantially Equivalent | |
| K002929 | DORNIER COMPACT ALPHA LITHOTRIPTER | LNS | Substantially Equivalent | |
| K983963 | DORNIER MEDILA H | GEX | Substantially Equivalent | |
| K964760 | DORNIER MEDILAS FIBER TOME LASER | GEX | Substantially Equivalent | |
| K955019 | UROTRACT I | KQS | Substantially Equivalent | |
| K921549 | DORNIER FIBERTOME 100 WATT SURGICAL LASER | GEX | Substantially Equivalent | |
| K913191 | DORNIER LASER LITHOTRIPTER IMPACT | GEX | Substantially Equivalent | |
| K904149 | FLEXISYS | GEX | Substantially Equivalent | |
| K904155 | MEDILAS 4060N FIBERTOM(R) SURGICAL LASER | GEX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1037955 | 1037955 | DORNIER MEDTECH AMERICA, INC. | 1155 ROBERTS BLVD., KENNESAW, GA 30144 US | 2026 | and 9 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KDQBottle, Collection, Vacuum
- EOQBronchoscope (Flexible Or Rigid)
- EYBCatheter, Ureteral, Gastro-Urology
- FAJCystoscope And Accessories, Flexible/Rigid
- EZNDilator, Catheter, Ureteral
- KOEDilator, Urethral
- FGODislodger, Stone, Flexible
- FASElectrode, Electrosurgical, Active, Urological
- FEDEndoscopic Access Overtube, Gastroenterology-Urology
- PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, Exempt
- NBNGenerator, Shock-Wave, For Pain Relief
- OXOImage-Intensified Fluoroscopic X-Ray System, Mobile
- OWBInterventional Fluoroscopic X-Ray System
- GCJLaparoscope, General & Plastic Surgery
- LNSLithotriptor, Extracorporeal Shock-Wave, Urological
- GEXPowered Laser Surgical Instrument
- FADStent, Ureteral
- EYAStylet, Ureteral
- MEQSystem, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- KQSTable, Cystometric, Non-Electric And Accessories
- FGBUreteroscope And Accessories, Flexible/Rigid
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1381-2019 | Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Number/Description: K1001291 600 micron single use fiber K2011824 600 micron single use fiber K1001293 600 micron single use fiber K2011826 600 micron 5X reusable fiber K1008084 600 micron single use fiber K2011828 400 micron 5X reusable fiber K1010500 600 micron fibertome fiber K2012021 600 micron single use fiber K1015640 AngioSpot Fiber Kit K2012393 600 micron single use fiber K2010292 400 micron single use fiber K2012439 600 micron 5X reusable fiber K2010667 micron ITT fiber K2012875 600 micron 3X reusable fiber K2010710 400 micron single use fiber K2012879 400 micron 3X reusable fiber K2011822 400 micron single use fiber Product Usage: The Dornier Diode Fibers are accessories to the Dornier Medilas D Family Lasers. The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT, and Radiology. The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse. and Medilas D MagnaPulse, are intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment and/or removal of vascular lesions (tumors) and removal of unwanted hair, for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux and treatment of reticular veins and branch varicosities. The Dornier Medilas D Family Lasers, specifically the Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 28-85 cc. | Pin hole package failures compromising sterility of product | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Dornier Medtech America, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain