FDA 510(k) Applications for Medical Device:
Light, Surgical, Fiberoptic
| FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
| K093386 |
BFW, INC |
2307 RIVER ROAD
| LOUISVILLE |
KY |
40206 |
| K051786 |
DESIGNS FOR VISION, INC. |
49 PLAIN STREET
| NORTH ATTLEBORO |
MA |
02760 |
| K141330 |
ENROXTECH, INC. |
4655 KIRKWOOD COURT
| BOULDER |
CO |
80301 |
| K061690 |
GULF MEDICAL FIBEROPTICS |
148 DUNBAR AVE., UNIT B
| OLDSMAR |
FL |
34677 |
| K200874 |
Innovasis, Inc. |
614 East 3900 South
| Salt Lake City |
UT |
84107 |
| K113697 |
INVUITY, INC. |
39 STILLMAN STREET
| SAN FRANCISO |
CA |
94107 |
| K090070 |
INVUITY, INC. |
155-A MOFFETT PARK DRIVE
| SUNNYVALE |
CA |
94089 |
| K991572 |
ISOLUX AMERICA |
1479 RAILHEAD BLVD.
| NAPLES |
FL |
34110-8444 |
| K102266 |
ISOLUX LLC |
1045 COLLIER CENTER WAY
| NAPLES |
FL |
34110-8444 |
| K100388 |
MEDICAL ILLUMINATION INTERNATIONAL, INC. |
547 LIBRARY ST.
| SAN FERNANDO |
CA |
91340 |
| K053227 |
MEDICAL ILLUMINATION INTERNATIONAL, INC. |
547 LIBRARY ST.
| SAN FERNANDO |
CA |
91340 |
| K000728 |
MEDTRONIC XOMED |
6743 SOUTHPOINT DR. NORTH
| JACKSONVILLE |
FL |
32216 |
| K042034 |
NUVASIVE, INC. |
10065 OLD GROVE RD.
| SAN DIEGO |
CA |
92131 |
| K955510 |
PRODUCTS FOR MEDICINE |
3722 AVE.
| IRVINE |
CA |
92714 |
| K113330 |
SENSORMED |
2450 EJ CHAPMAN DR.,
| KNOXVILLE |
TN |
37996 |
| K101496 |
SENSORMED |
2450 EJ CHAPMAN DR., SUITE 104
| KNOXVILLE |
TN |
37996 |
| K082992 |
SPINAL ELEMENTS, INC. |
2744 LOKER AVE. W. SUITE 100
| CARLSBAD |
CA |
92010 |
| K100395 |
STERIS Corporation |
5960 Heisley Road
| Mentor |
OH |
44060 |
| K003577 |
STERIS Corporation |
2720 GUNTER PARK EAST
| MONTGOMERY |
AL |
36109 |
| K122637 |
STRYKER SPINE |
2 PEARL COURT
| ALLENDALE |
NJ |
07401 |
| K083710 |
THOMAS SURGICAL INSTRUMENTS, INC. |
10170 E. CHERRY BEND RD.
| TRAVERSE CITY |
MI |
49684 |
| K080962 |
THOMPSON SURGICAL INSTRUMENTS, INC. |
10170 EAST CHERRY BEND ROAD
| TRAVERSE CITY |
MI |
49684 |
| K972225 |
UNIVERSAL FIBEROPTIC REPAIR, INC. |
9 WRIGHTS CROSSING
| POMFRET CENTER |
CT |
06259 |
| K071218 |
WELCH ALLYN, INC. |
4341 STATE STREET ROAD
| SKANEATELES FALLS |
NY |
13153-0220 |
| K080367 |
ZIMMER SPINE, INC. |
7375 BUSH LAKE RD.
| MINNEAPOLIS |
MN |
55439 |
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