FDA 510(k) Applications for Medical Device:
Holder, Head, Neurosurgical (Skull Clamp)
FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
K122225 |
BRAINLAB AG |
KAPELLENSTRASSE 12
| FELDKIRCHEN |
|
85622 |
K090695 |
DINKLER SURGICAL DEVICES, INC. |
174 LOOKOUT DRIVE
| DAYTON |
OH |
45419 |
K073163 |
DINKLER SURGICAL DEVICES, INC. |
174 LOOKOUT DRIVE
| DAYTON |
OH |
45419 |
K031885 |
IMAGE-GUIDED NEUROLOGICS, INC. |
2290 EAU GALLIE BLVD.
| MELBOURNE |
FL |
32935 |
K103493 |
IMRIS, INC. |
16809 BRIARDALE ROAD
| ROCKVILLE |
MD |
20855 |
K141950 |
IMRIS, INC. |
5101 Shady Oak Rd
| Minnetonka |
MN |
55343 |
K113748 |
IMRIS, INC. |
100-1370 SONY PLACE
| WINNIPEG, MB |
|
R3T 1N5 |
K051440 |
INTEGRA LIFESCIENCES CORP. |
311C ENTERPRISE DRIVE
| PLAINSBORO |
NJ |
08536 |
K050319 |
INTEGRA LIFESCIENCES CORP. |
4900 CHARLEMAR DRIVE,
| CINCINATTI |
OH |
45227 |
K081401 |
INTEGRA LIFESCIENCES CORP. |
311 ENTERPRISE DR.
| PLAINSBORO |
NJ |
08536 |
K072208 |
INTEGRA LIFESCIENCES CORPORATION |
311 ENTERPRISE DR.
| PLAINSBORO |
NJ |
08536 |
K130389 |
INTEGRA LIFESCIENCES CORPORATION |
311 ENTERPRISE DR.
| PLAINSBORO |
NJ |
08536 |
K090506 |
INTEGRA LIFESCIENCES CORPORATION |
4900 CHARLEMAR DR.,
| CINCINNATI |
OH |
45227 |
K071458 |
INTEGRA LIFESCIENCES CORPORATION |
311 ENTERPRISE DR.
| PLAINSBORO |
NJ |
08536 |
K120633 |
INTEGRA LIFESCIENCES CORPORATION |
311 ENTERPRISE DR.
| PLAINSBORO |
NJ |
08536 |
K142238 |
INTEGRA LIFESCIENCES CORPORATION |
311 ENTERPRISE DR.
| PLAINSBORO |
NJ |
08536 |
K053045 |
INTEGRA LIFESCIENCES CORPORATION |
311 ENTERPRISE DR.
| PLAINSBORO |
NJ |
08536 |
K083803 |
MEDICON, E.G. |
GAENSAECKER 15
| TUTTLINGEN |
|
D-78532 |
K955012 |
MIZUHO AMERICA, INC. |
123 BRIMBAL AVE.
| BEVERLY |
MA |
01915 |
K191701 |
MRI Interventions, Inc. |
5 Musick
| Irvine |
CA |
92618 |
K953124 |
OHIO MEDICAL INSTRUMENT CO., INC. |
3924 VIRGINIA AVE.
| CINCINNATI |
OH |
45227 |
K021604 |
OHIO MEDICAL INSTRUMENT CO., INC. |
4900 CHARLEMAR DR.
| CINCINNATI |
OH |
45227 |
K191740 |
Pro Med Instruments GmbH |
Boetzinger Str. 38
| Freiburg |
|
79111 |
K203505 |
pro med instruments GmbH |
Boetziger Str. 38
| Freiburg |
|
79111 |
K191979 |
Pro Med Instruments GmbH |
Boetzinger Str. 38
| Freiburg |
|
79111 |
K193438 |
Pro Med Instruments GmbH |
Boetzinger Str. 38
| Freiburg |
|
79111 |
K001808 |
PRO-MED INSTRUMENTS GMBH |
9070 BLUFFVIEW TRACE
| ROSWELL |
GA |
30076 |
K063494 |
PRO-MED INSTRUMENTS GMBH |
5450 LEE ST, STE 1
| LEHIGH ACRES |
FL |
33971 |
K032331 |
PRO-MED INSTRUMENTS GMBH |
1899 SAWYER LANE
| ALVA |
FL |
33920 |
K091439 |
SURGIVISION, INC. |
11874 SOUTH EVELYN CIRCLE
| HOUSTON |
TX |
77071 |
K163322 |
TZ MEDICAL INC |
17750 SW UPPER BOONES FERRY RD #150
| PORTLAND |
OR |
97224 |
K002276 |
V. MUELLER NEURO/SPINE |
360 INDUSTRIAL RD., UNIT H
| SAN CARLOS |
CA |
94070 |
K002990 |
VASCULAR TECHNOLOGY INCORPORATED |
175 CABOT ST.
| LOWELL |
MA |
01854 |
|
|