Company ยท US
Dornier Medtech America, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2025. Name variants (Inc, Corp, punctuation) are merged.
46510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEX | Powered Laser Surgical Instrument | 26 |
| LNS | Lithotriptor, Extracorporeal Shock-Wave, Urological | 8 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 5 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 2 |
| EYB | Catheter, Ureteral, Gastro-Urology | 1 |
| EZN | Dilator, Catheter, Ureteral | 1 |
| FAD | Stent, Ureteral | 1 |
| FAS | Electrode, Electrosurgical, Active, Urological | 1 |
| KQS | Table, Cystometric, Non-Electric And Accessories | 1 |
| OWB | Interventional Fluoroscopic X-Ray System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 31, 2025 | K243820 | Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IV Dornier Medtech America | FED |
| Jun 26, 2024 | K233380 | TRIDENT Mobile Fluoroscopy System Dornier Medtech America | JAA |
| Feb 22, 2023 | K221903 | Delta III Pro Dornier Medtech America, Inc. | LNS |
| Jul 27, 2022 | K213252 | Dornier Thulio Dornier Medtech America, Inc. | GEX |
| Apr 18, 2022 | K220871 | Nautilus Dornier Medtech America, Inc. | JAA |
| May 19, 2021 | K210394 | Electrosurgical accessory Dornier Medtech America, Inc. | FAS |
| Nov 20, 2020 | K201815 | Dornier MAGELLAN Ureteral Access Sheath Dornier Medtech America, Inc. | FED |
| Sep 3, 2020 | K201074 | Delta III Lithotripter Dornier Medtech America, Inc. | LNS |
| Dec 6, 2019 | K190612 | EQUINOX Balloon Dilatation Catheter Dornier Medtech America, Inc. | EZN |
| Nov 15, 2019 | K190312 | Dornier Ureteral Stent Dornier Medtech America, Inc. | FAD |
| Sep 18, 2019 | K191187 | Dornier MINNOW Ureteral Catheter Dornier Medtech America, Inc. | EYB |
| Mar 7, 2018 | K180350 | Dornier Medilas H Solvo 35 Laser Dornier Medtech America | GEX |
| Aug 8, 2017 | K172084 | Delta III Lithotripter Dornier Medtech America, Inc. | LNS |
| Jun 28, 2017 | K170122 | Delta III Lithotripter Dornier Medtech America | LNS |
| Jul 28, 2016 | K161771 | Medilas H Laser Fibers Dornier Medtech America, Inc. | GEX |
| Oct 8, 2015 | K152591 | Medilas H RFID Laser Fibers Dornier Medtech America, Inc. | GEX |
| Jul 30, 2015 | K151298 | Gemini XXP-HP Dornier Medtech America | LNS |
| Jun 30, 2015 | K151485 | GENESIS Dornier Medtech America, Inc. | JAA |
| Nov 26, 2014 | K133434 | GENESIS II Dornier Medtech America, Inc. | JAA |
| Sep 23, 2013 | K132672 | EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER Dornier Medtech America | LNS |
| Mar 21, 2013 | K130344 | DORNIER MEDILAS UROPULSE Dornier Medtech America, Inc. | GEX |
| Feb 1, 2013 | K122159 | DORNIER MEDILAS H30 SOLVO Dornier Medtech America, Inc. | GEX |
| Jan 18, 2013 | K122768 | GENESIS Dornier Medtech America, Inc. | JAA |
| Dec 14, 2012 | K123385 | MEDILAS H LASER FIBERS Dornier Medtech America, Inc. | GEX |
| Sep 24, 2012 | K121656 | GEMINI LITHOTRIPTER Dornier Medtech America, Inc. | LNS |
| Aug 1, 2012 | K121938 | MEDILAS H RFID LASER FIBER Dornier Medtech America, Inc. | GEX |
| Dec 7, 2011 | K110364 | DORNIER MEDILAS D LITEBEAM+ 1470 Dornier Medtech America, Inc. | GEX |
| Feb 12, 2009 | K083500 | MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE Dornier Medtech America, Inc. | GEX |
| Jan 30, 2009 | K083258 | MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE Dornier Medtech America, Inc. | GEX |
| Aug 20, 2008 | K073427 | MEDILAS D FAMILY LASERS Dornier Medtech America, Inc. | GEX |
| Jun 27, 2008 | K080959 | DORNIER MEDILAS D 30 LASER, MEDILAS D 1064 Dornier Medtech America, Inc. | GEX |
| May 21, 2007 | K070536 | MEDILAS D FAMILY LASERS Dornier Medtech America, Inc. | GEX |
| Mar 9, 2007 | K070123 | TCA 5R / 5S Dornier Medtech America, Inc. | OWB |
| Aug 1, 2006 | K061455 | DORNIER MEDILAS H 20 LASER Dornier Medtech America, Inc. | GEX |
| Oct 25, 2002 | K020339 | DORNIER DIODE LASER FAMILY MEDILAS D, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEM Dornier Medtech America, Inc. | GEX |
| Aug 21, 2002 | K022544 | DORNIER MEDILAS H LASER FIBER CABLES Dornier Medtech America, Inc. | GEX |
| Aug 19, 2002 | K021724 | DORNIER DIODE LASER FAMILY, INCLUDING MEDILAS D FIBERTOM, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEMS Dornier Medtech America, Inc. | GEX |
| Nov 19, 2001 | K011322 | DORNIER SAPPHIREERBIUM HANDPIECE, DORNIER SAPPHIRESPOT HANDPIECE Dornier Medtech America, Inc. | GEX |
| Apr 17, 2001 | K002929 | DORNIER COMPACT ALPHA LITHOTRIPTER Dornier Medtech America, Inc. | LNS |
| Nov 25, 1998 | K983963 | DORNIER MEDILA H Dornier Medtech America, Inc. | GEX |
| Feb 19, 1997 | K964760 | DORNIER MEDILAS FIBER TOME LASER Dornier Medtech America, Inc. | GEX |
| Dec 6, 1995 | K955019 | UROTRACT I Dornier Medtech America, Inc. | KQS |
| Feb 18, 1993 | K921549 | DORNIER FIBERTOME 100 WATT SURGICAL LASER Dornier Medtech America, Inc. | GEX |
| Oct 16, 1991 | K913191 | DORNIER LASER LITHOTRIPTER IMPACT Dornier Medtech America, Inc. | GEX |
| Dec 4, 1990 | K904149 | FLEXISYS Dornier Medtech America, Inc. | GEX |
| Nov 21, 1990 | K904155 | MEDILAS 4060N FIBERTOM(R) SURGICAL LASER Dornier Medtech America, Inc. | GEX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2019 | Dornier Medtech America, Inc. 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 f Terminated |
GEX | K083500 |