FDA 510(k) Applications for Medical Device:
Tonometer, Manual
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K132549 | ACCUTOME, INC. |
3222 PHOENIXVILLE PIKE | MALVERN | PA | 19355 |
| K992998 | AUTOMATED OPHTHALMICS, INC. |
8253 GLEMAR RD. | ELLICOTT | MD | 21043 |
| K011199 | BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST. | ROCHESTER | NY | 14609-3547 |
| K991840 | BERNARD B. FRESCO |
40 SAINT CLAIR AVE EAST 303 | TORONTO, ONTARIO | M4T 1M9 | |
| K022054 | C.S.O. S.R.L. |
197 BELVOIR RD. | WILLIAMSVILLE | NY | 14221 |
| K180839 | Carl Zeiss Meditec AG |
Goeschwitzer Strasse 51-52 | Jena | 07745 | |
| K203850 | CATS Tonometer LLC |
1517 N. Wilmot | Tucson | AZ | 85712 |
| K173904 | CATS Tonometer, LLC |
1517 N. Wilmot, Suite 143 | Tucson | AZ | 85712 |
| K191314 | Chongqing Sunkingdom Medical Instrument Co., Ltd |
1012, Block A of China Resource Center No.55 of XieJiaWan | Chongqing | 400050 | |
| K961512 | CLEMENT CLARKE, INC. |
AIRMED HOUSE, EDINBURGH WAY | ENGLAND | ||
| K992835 | CSO |
197 BELVOIR RD. | WILLIAMSVILLE | NY | 14221 |
| K032769 | EYE-DEAS, LLC |
39 SANDRINGHAM RD. | ROCHESTER | NY | 14610 |
| K071755 | FALCK MEDICAL INC. |
15825 SHADY GROVE RD.,SUITE 30 | ROCKVILLE | MD | 20850 |
| K151491 | FALCK MEDICAL, INC |
35 WASHINGTON STREET | MYSTIC | CT | 06355 |
| K981432 | GOLDEN VISION, INC. |
7436 S.W. 117TH AVE.,SUITE 103 | MIAMI | FL | 33183-3816 |
| K163343 | Icare Finland Oy |
Ayritie 22 | Vantaa | 01510 | |
| K200966 | Icare Finland Oy |
Ayritie 22 | Vantaa | 01510 | |
| K211355 | Icare Finland Oy |
Ayritie 22 | Vantaa | 01510 | |
| K153694 | Icare Finland Oy |
Ayritie 22 | Vantaa | FI-01510 | |
| K190316 | Icare Finland Oy |
Ayritie 22 | Vantaa | 01510 | |
| K220852 | Icare Finland Oy |
Ayritie 22 | Vantaa | 01510 | |
| K152644 | KEELER LIMITED |
CLEWER HILL ROAD | WINDSOR | SL4 4AA | |
| K133234 | KEELER LIMITED |
456 PARKWAY | BROOMALL | PA | 19008 |
| K142179 | KEELER LTD. |
456 PARKWAY | BROOMALL | PA | 19008 |
| K093445 | KEELER LTD. |
456 PARKWAY | BROOMALL | PA | 19008 |
| K960924 | KOWA OPTIMED, INC. |
700 THIRTEENTH STREET, N.W. | WASHINGTON | DC | 20005 |
| K023838 | LUNEAU SA |
BP 252 | CHARTRES CEDEX | 28005 | |
| K053430 | MEDTRONIC XOMED, INC. |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216 |
| K964312 | MENTOR OPHTHALMICS, INC. |
3000 LONGWATER DR. | NORWELL | MA | 02061-1672 |
| K132917 | OCULAR THERAPEUTIX, INC. |
36 Crosby Dr Ste 101 | Bedford | MA | 01730 |
| K970887 | PARADIGM MEDICAL INDUSTRIES, INC. |
1772 WEST 2300 SOUTH | SALT LAKE CITY | UT | 84119 |
| K000288 | REICHERT OPHTHALMIC INSTRUMENTS, DIV. LEICA, INC. |
3374 WALDEN AVE. | DEPEW | NY | 14043 |
| K070534 | REICHERT, INC. |
3362 WALDEN AVE. | DEPEW | NY | 14043 |
| K152308 | SENSOR MEDICAL TECHNOLOGY, LLC |
23175 224th Place SE | Maple Valley | WA | 98038 |
| K142263 | SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO. LTD. |
Zone A, 2nd Floor, No. 69, Lane | SHANGHAI | 200237 | |
| K032967 | SMT SWISS MICROTECHNOLOGY AG |
13 RED FOX LANE | LITTLETON | CO | 80127 |
| K172728 | TAKAGI SEIKO CO., LTD. |
330-2 | Nakano-shi | 383-8585 | |
| K182491 | Takagi Seiko Co., Ltd. |
330-2 | Nakano-Shi | 383-8585 | |
| K063873 | TIOLAT OY |
8404 SUNSTATE STREET | TAMPA | FL | 33634 |
| K033146 | TRA & ACCESSORIES |
449 WEST ALLEN AVE. SUITE 107 | SANDIMAS | CA | 91773 |
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