FDA 510(k) Applications for Medical Device:
Endoscope, Neurological
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K061135 | AESCULAP |
1499 DELP DRIVE | HARLYSVILLE | PA | 19438 |
| K964281 | AESCULAP, INC. |
1000 GATEWAY BLVD. | SOUTH SAN FRANCISCO | CA | 94080 |
| K983365 | AESCULAP, INC. |
1000 GATEWAY BLVD. | SOUTH SAN FRANCISCO | CA | 94080 |
| K954394 | AESCULAP, INC. |
1000 GATEWAY BLVD. | SOUTH SAN FRANCISCO | CA | 94080 |
| K142315 | AESCULAP, INC. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K014149 | AESCULAP, INC. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K181116 | Carl Zeiss Meditec AG |
Goeschwitzer Str. 51-52 | Jena | 07745 | |
| K232159 | Carl Zeiss Meditec AG |
Rudolf-Eber-Strasse | Oberkochen | 73447 | |
| K170667 | Carl Zeiss Meditec AG |
Goeschwitzer Strasse 51-52 | Jena | 07745 | |
| K960915 | CLARUS MEDICAL SYSTEMS, INC. |
1000 BOONE AVENUE NORTH | MINNEAPOLIS | MN | 55427-8656 |
| K955598 | CLARUS MEDICAL SYSTEMS, INC. |
1000 BOONE AVENUE NORTH | MINNEAPOLIS | MN | 55427-8656 |
| K200925 | Clarus Medical, LLC |
13355 10th Ave N Suite 110 | Plymouth | MN | 55441 |
| K201308 | ClearMind Biomedical |
5f, No 167, Fuxing N. Rd., Songshan | Taipei | 105021 | |
| K210251 | ClearMind Biomedical |
5F, No. 167, Fuxing N. Rd., Songshan Dist. | Taipei | 105403 | |
| K982819 | ENDIUS, INC. |
45 PONTIAC RD. | NEWTON | MA | 02468 |
| K052745 | GEOMED MEDIZIN-TECHNIK GMBH & CO. |
AMSTEL 320-I | AMSTERDAM | 1017AP | |
| K222735 | HJY Smart Medical Device Co., Ltd. |
12F., No. 415, Sec. 4, Xinyi Dist. | Taipei City | 11051 | |
| K002330 | IMAGE-GUIDED NEUROLOGICS, INC. |
2290 EAU GALLIE BLVD. | MELBOURNE | FL | 32935 |
| K001630 | KARL STORZ ENDOSCOPY |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K982837 | KARL STORZ ENDOSCOPY |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K162880 | KARL STORZ Endoscopy America, Inc |
2151 E. Grand Avenue | El Segundo | CA | 90245 |
| K180146 | KARL STORZ Endoscopy America, Inc. |
2151 E. Grand Avenue | El Segundo | CA | 90245 |
| K993539 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K161112 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
2151 E. GRAND AVENUE | EL SEGUNDO | CA | 90245 |
| K170462 | KARL STORZ Endoscopy-America, Inc. |
2151 E. Grand Avenue | EI Segundo | CA | 90245 |
| K072410 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K002704 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K002788 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K991069 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K021050 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K993568 | MACHIDA ENDOSCOPE CO., LTD. |
13-8, HONKOMAGOME 6-CHOME, | TOKYO | ||
| K180270 | Mauna Kea Technologies |
9 Rue d'Enghien | Paris | 75010 | |
| K002572 | MEDTRONIC PS MEDICAL |
125 CREMONA DR. | GOLETA | CA | 93117-5500 |
| K990333 | MEDTRONIC PS MEDICAL |
125 CREMONA DR. | GOLETA | CA | 93117-5500 |
| K010341 | MEDTRONIC PS MEDICAL |
125 CREMONA DR. | GOLETA | CA | 93117-5500 |
| K003914 | MEDTRONIC PS MEDICAL |
125 CREMONA DR. | GOLETA | CA | 93117-5500 |
| K991989 | MITAKA USA, INC. |
2337 LUCKY JOHN DR. | PARK CITY | UT | 84060 |
| K181731 | MRI Interventions, Inc. |
5 Musick | Irvine | CA | 92618 |
| K961173 | NEURO NAVIGATIONAL CORP. |
3180 PULLMAN ST. | COSTA MESA | CA | 92626 |
| K965078 | NEURO NAVIGATIONAL CORP. |
3180 PULLMAN ST. | COSTA MESA | CA | 92626 |
| K961300 | NEURO NAVIGATIONAL CORP. |
3180 PULLMAN ST. | COSTA MESA | CA | 92626 |
| K960792 | NEURO NAVIGATIONAL CORP. |
3180 PULLMAN ST. | COSTA MESA | CA | 92626 |
| K954938 | NEURO NAVIGATIONAL CORP. |
3180 PULLMAN ST. | COSTA MESA | CA | 92626 |
| K955351 | NEURO NAVIGATIONAL CORP. |
3180 PULLMAN ST. | COSTA MESA | CA | 92626 |
| K961406 | NEURO NAVIGATIONAL CORP. |
3180 PULLMAN ST. | COSTA MESA | CA | 92626 |
| K043128 | OLYMPUS CORPORATION |
TWO CORPORATE CENTER DRIVE | MELVILLE | NY | 11747-3157 |
| K013759 | OLYMPUS OPTICAL CO., LTD. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K971340 | OLYMPUS OPTICAL, CO. |
55 NORTHERN BLVD., SUITE 410 | GREAT NECK | NY | 11021 |
| K020507 | OLYMPUS WINTER & IBE GMBH |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K132931 | PENUMBRA, INC. |
1351 HARBOR BAY PARKWAY | ALAMEDA | CA | 94502 |
| K152699 | PENUMBRA, INC. |
ONE PENUMBRA PLACE | ALAMEDA | CA | 94502 |
| K190719 | Penumbra, Inc. |
One Penumbra Place | Alameda | CA | 94502 |
| K171332 | Penumbra, Inc. |
One Penumbra Place | Alameda | CA | 94502 |
| K191861 | Rebound Therapeutics |
13900 Alton Parkway Suite 120 | Irvine | CA | 92618 |
| K201840 | Rebound Therapeutics |
13900 Alton Parkway Suite 120 | Irvine | CA | 92618 |
| K182211 | Rebound Therapeutics Corporation |
13900 Alton Parkway | Irvine | CA | 92618 |
| K022198 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
353 CORPORATE WOODS PKWY. | VERNON HILLS | IL | 60061 |
| K031858 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
353 CORPORATE WOODS PKWY. | VERNON HILLS | IL | 60061 |
| K970162 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
353 CORPORATE WOODS PKWY. | VERNON HILLS | IL | 60061 |
| K963642 | SOFAMOR DANEK USA,INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K211202 | Stryker |
5900 Optical Court | San Jose | CA | 95138 |
| K131434 | VISIONSENSE, LTD. |
555 13TH STREET, NW | WASHINGTON | DC | 20004 |
| K081102 | VISIONSENSE, LTD. |
555 13TH STREET, NW | WASHINGTON | DC | 20004 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
