FDA 510(k) Applications for Medical Device:
Device, Monitoring, Intracranial Pressure
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K003759 | AESCULAP, INC. |
200 GREGORY LN. | PLEASENT HILL | CA | 94523-3389 |
| K201989 | Braincare Desenvolvimento e Inovacao Tecnologica S.A. |
Avenida Bruno Ruggiero Filho, 971 | Sao Carlos | 13562-420 | |
| K182073 | Braincare desenvolvimento e Inovacao Tecnologica S.A. |
Rua Cid Silva Cesar, 600 sala 6, | Sao Carlos | 13562-400 | |
| K240821 | Braincare Desenvolvimento e Inovaτπo Tecnol≤gica S.A. |
Avenida Bruno Ruggiero Filho, 971 | Sπo Carlos | 13562-420 | |
| K172209 | Branchpoint Technologies, INC. |
1 Technology Drive, Suite I-811 | Irvine | CA | 92618 |
| K962928 | CAMINO NEUROCARE, INC. |
5955 PACIFIC CENTER BLVD. | SAN DIEGO | CA | 92121 |
| K981846 | CAMINO NEUROCARE, INC. |
5955 PACIFIC CENTER BLVD. | SAN DIEGO | CA | 92121 |
| K982702 | CAMINO NEUROCARE, INC. |
5955 PACIFIC CENTER BLVD. | SAN DIEGO | CA | 92121 |
| K020285 | CMA MICRODIALYSIS AB |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K060554 | CMA MICRODIALYSIS AB |
73 PRINCETON STREET | NORTH CHELMSFORD | MA | 01863 |
| K071984 | CMA MICRODIALYSIS AB |
73 PRINCETON STREET | NORTH CHELMSFORD | MA | 01863 |
| K102077 | CMA MICRODIALYSIS AB |
73 PRINCETON STREET | NORTH CHELMSFORD | MA | 01863 |
| K173192 | Codman & Shurtleff, Inc |
325 Paramount Drive | Raynham | MA | 02767 |
| K153347 | CODMAN & SHURTLEFF, INC. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767 |
| K992591 | Codman & Shurtleff, Inc. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K980380 | DIAMETRICS MEDICAL, LTD. |
SHORT STREET | HIGH WYCOMBE, BUCKINGHAMSHIRE | HP11 2QH | |
| K101133 | DPCOM AS |
435 RICE CREEK TERRACE | FRIDLEY | MN | 55432 |
| K032337 | HEMEDEX INCORPORATED |
7 TIFFANY TRAIL | HOPKINTON | MA | 01748 |
| K141869 | HEMEDEX INCORPORATED |
222 3rd St Suite 0123 | CAMBRIDGE | MA | 02142 |
| K161010 | InnerSpace Neuro Solutions, Inc. |
1622 Edinger Ave Suite C | Tustin | CA | 92780 |
| K113088 | INNERSPACE, INC |
1622 EDINGER AVE STE C | TUSTIN | CA | 92780 |
| K010422 | INNERSPACE, INC. |
2933 SOUTH PULLMAN ST., | SANTA ANA | CA | 92705 |
| K013705 | INNERSPACE, INC. |
2933 SOUTH PULLMAN ST., | SANTA ANA | CA | 92705 |
| K003905 | INNERSPACE, INC. |
2933 SOUTH PULLMAN ST., | SANTA ANA | CA | 92705 |
| K041838 | INNERSPACE, INC. |
2933 SOUTH PULLMAN ST., | SANTA ANA | CA | 92705 |
| K072379 | INNERSPACE, INC. |
1622 EDINGER AVENUE, SUITE C | TUSTIN | CA | 92780 |
| K083378 | INNERSPACE, INC. |
1622 EDINGER AVENUE, SUITE C | TUSTIN | CA | 92780 |
| K121159 | INTEGRA LIFESCIENCE CORPORTATION |
311 ENTERPRISE DRIVE | PLAINSBORO | NJ | 08536 |
| K183406 | Integra LifeSciences Corp. |
11 Cabot Blvd | Mansfield | MA | 02048 |
| K131184 | INTEGRA LIFESCIENCES CORP. |
22 TERRY AVENUE | BURLINGTON | MA | 01830 |
| K053244 | INTEGRA LIFESCIENCES CORP. |
311C ENTERPRISE DRIVE | PLAINSBORO | NJ | 08536 |
| K102875 | INTEGRA LIFESCIENCES CORPORATION |
311 ENTERPRISE DR. | PLAINSBORO | NJ | 08536 |
| K133754 | INTEGRA LIFESCIENCES CORPORATION |
311 ENTERPRISE DRIVE | PLAINSBORO | NJ | 08535 |
| K061640 | INTEGRA LIFESCIENCES CORPORATION |
311 ENTERPRISE DR. | PLAINSBORO | NJ | 08536 |
| K040235 | INTEGRA LIFESCIENCES CORPORATION |
311 ENTERPRISE DR. | PLAINSBORO | NJ | 08536 |
| K071505 | INTEGRA LIFESCIENCES CORPORATION |
311 ENTERPRISE DR. | PLAINSBORO | NJ | 08536 |
| K210993 | Integra LifeSciences Production Corporation |
11 Cabot Boulevard | Mansfield | MA | 02048 |
| K232890 | Integra LifeSciences Production Corporation |
11 Cabot Boulevard | Mansfield | MA | 02048 |
| K031086 | INTEGRA NEURO SCIENCES |
5955 PACIFIC CENTER BLVD. | SAN DIEGO | CA | 92121 |
| K002392 | INTEGRA NEUROCARE LLC. |
5955 PACIFIC CENTER BLVD. | SAN DIEGO | CA | 92121 |
| K022553 | INTEGRA NEUROSCIENCES |
5955 PACIFIC CENTER BLVD. | SAN DIEGO | CA | 92121 |
| K020558 | INTEGRA NEUROSCIENCES |
5955 PACIFIC CENTER BLVD. | SAN DIEGO | CA | 92121 |
| K002765 | INTEGRA NEUROSCIENCES |
5955 PACIFIC CENTER BLVD. | SAN DIEGO | CA | 92121 |
| K050720 | INTEGRA NEUROSCIENCES |
311 ENTERPRISE DR. | PLAINSBORO | NJ | 08536 |
| K121573 | INTRGRA LIFESCIENCES CORPORATION |
311 ENTERPRISE DRIVE | PLAINSBORO | NJ | 08536 |
| K974088 | JOHNSON & JOHNSON PROFESSIONALS, INC. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767 |
| K991222 | JOHNSON & JOHNSON PROFESSIONALS, INC. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767 |
| K020780 | MEDEX, INC. |
6250 SHIER RINGS RD. | DUBLIN | OH | 43016 |
| K152670 | Medos International SARL |
Chemin-Blanc 38 | Le Locle | CH-2400 | |
| K983799 | MEDTRONIC PS MEDICAL |
125 CREMONA DR. | GOLETA | CA | 93117-5500 |
| K200456 | Medtronic, Inc. |
125 Cremona Drive | Goleta | CA | 93117 |
| K201118 | Medtronic, Inc. |
5290 California Ave | Irvine | CA | 92617 |
| K200630 | Medtronic, Inc. |
5290 California Ave | Irvine | CA | 92617 |
| K022638 | NEURORECOVERY, INC. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K051599 | NEURORECOVERY, INC. |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K050702 | NEUROSYSTEMS LLC |
103 POMFRET ROAD | WOODSTOCK | VT | 05091-8029 |
| K042728 | NOVUS MONITORING LTD |
311 ENTERPRISE DRIVE | PLAINSBORO | NJ | 08536 |
| K013930 | NOVUS MONITORING LTD |
ABBOTTS ANN, ANDOVER | UNITED KINGDOM | SP11 7BH | |
| K171666 | Raumedic AG |
Hermann-Staudinger-Strasse 2 | Helmbrechts | 95233 | |
| K112017 | RAUMEDIC AG |
HERRMANN-STAUDINGER-STR. 2 | HELMBRECHTS | D 95233 | |
| K103206 | RAUMEDIC AG |
HERRMANN-STAUDINGER-STR. 2 | HELMBRECHTS | D 95233 | |
| K120252 | RAUMEDIC AG |
HERRMANN-STAUDINGER-STR. 2 | HELMBRECHTS | D 95233 | |
| K130529 | RAUMEDIC AG |
HERRMANN-STAUDINGER-STR. 2 | HELMBRECHTS | 95233 | |
| K062584 | SOPHYSA SA |
2884 DANAPOPLAR | DANA POINT | CA | 92629 |
| K162108 | SOPHYSA, SA |
5, rue Guy Moquet | ORSAY, Cedex | 91400 |
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