FDA 510(k) Applications for Medical Device:
Shunt, Central Nervous System And Components
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K161853 | AESCULAP INC. |
3773 CORPORATE PARKWAY | CENTER VALLEY | PA | 18034 |
| K242003 | Aesculap Inc. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K141687 | AESCULAP, INC. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K030698 | AESCULAP, INC. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K011030 | AESCULAP, INC. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K103003 | AESCULAP, INC. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K110206 | AESCULAP, INC. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K062009 | AESCULAP, INC. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K120559 | AESCULAP, INC. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K031303 | AESCULAP, INC. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K192266 | Aesculap, Inc. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K190174 | Aesculap, Inc. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K200950 | Aesculap, Inc. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K172006 | Alcyone Lifesciences. Inc. |
250 Jackson Street Mill No. 5, Unit 494 | Lowell | MA | 01852 |
| K221918 | Anuncia Medical, Inc. |
1355 N Scottsdale Rd, Suite 370 | Scottsdale | AZ | 85257 |
| K223603 | Anuncia Medical, Inc. |
1355 N Scottsdale Rd, Suite 370 | Scottsdale | AZ | 85257 |
| K171586 | Aqueduct Critical Care, Inc |
11822 North Creek Parkway North, Suite 110 | Bothell | WA | 98011 |
| K161605 | AQUEDUCT CRITICAL CARE, INC. |
11822 NORTH CREEK PARKWAY NORTH | Bothell | WA | 98011 |
| K172759 | Aqueduct Critical Care, Inc. |
11822 North Creek Parkway North | Bothell | WA | 98011 |
| K181301 | Aqueduct Critical Care, Inc. |
11822 North Creek Parkway North | Bothell | WA | 98011 |
| K170599 | Arkis BioSciences Inc. |
1059 N. Cedar BluffRD #157 | Knoxville | TN | 37923 |
| K984583 | BIOMEDICS |
536 RIMPAU BLVD. | LOS ANGELES | CA | 90020 |
| K241458 | Borvo Medical Inc. |
2500 Old Middlefield Way | Mountain View | CA | 94043 |
| K172035 | BTG International, Inc. |
11911 North Creek Pkwy S | Bothell | WA | 98011 |
| K102589 | Codman & Shurtleff, Inc. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K110751 | Codman & Shurtleff, Inc. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K021653 | Codman & Shurtleff, Inc. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K090348 | Codman & Shurtleff, Inc. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K172537 | Codman & Shurtleff, Inc. |
325 Paramount Drive | Raynham | MA | 02767 |
| K061568 | Codman & Shurtleff, Inc. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K162437 | Codman & Shurtleff, Inc. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767 |
| K091346 | Codman & Shurtleff, Inc. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K053107 | Codman & Shurtleff, Inc. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K020667 | Codman & Shurtleff, Inc. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K172022 | Codman & Shurtleff, Inc. |
325 Paramount Drive | Raynham | MA | 02767 |
| K050739 | Codman & Shurtleff, Inc. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K061876 | Codman & Shurtleff, Inc. |
325 PARAMOUNT DRIVE | RAYNHAM | MA | 02767-3050 |
| K122118 | Codman & Shurtleff, Inc. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K003564 | Codman & Shurtleff, Inc. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K102961 | Codman & Shurtleff, Inc. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K053350 | Codman & Shurtleff, Inc. |
325 Paramount Drive | Raynham | MA | 02767 |
| K041296 | Codman & Shurtleff, Inc. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K962097 | COOK, INC. |
P.O. BOX 489 | BLOOMINGTON | IN | 47402 |
| K955265 | CORDIS CORP. |
14201 N.W. 60TH AVE. | MIAMI LAKES | FL | 33014 |
| K960159 | CORDIS CORP. |
14201 N.W. 60TH AVE. | MIAMI LAKES | FL | 33014 |
| K955832 | CORDIS CORP. |
14201 N.W. 60TH AVE. | MIAMI LAKES | FL | 33014 |
| K971799 | ELEKTA IMPLANTS, SA |
6011 CELLINI ST. | CORAL GABLES | FL | 33146 |
| K974726 | ELEKTA IMPLANTS, SA |
6011 CELLINI ST. | CORAL GABLES | FL | 33146 |
| K030081 | INMED LTDA. |
1308 MORNINGSIDE PARK DR. | ALPHARETTA | GA | 30022 |
| K181902 | Integra LifeSciences Corp. |
11 Cabot Blvd | Mansfield | MA | 02048 |
| K182265 | Integra LifeSciences Corp. |
11 Cabot Blvd | Mansfield | MA | 02048 |
| K030289 | INTEGRA LIFESCIENCES CORP. |
311 ENTERPRISE DR. | PLAINSBORO | NJ | 08536 |
| K092395 | INTEGRA LIFESCIENCES CORP. |
311 ENTERPRISE DR. | PLAINSBORO | NJ | 08536 |
| K042825 | INTEGRA LIFESCIENCES CORPORATION |
311 ENTERPRISE DR. | PLAINSBORO | NJ | 08536 |
| K153041 | INTEGRA LIFESCIENCES CORPORATION |
311 Enterprise Drive | PLAINSBORO | NJ | 08536 |
| K101381 | INTEGRA LIFESCIENCES CORPORATION |
311 ENTERPRISE DR. | PLAINSBORO | NJ | 08536 |
| K161992 | INTEGRA LIFESCIENCES CORPORATION |
311 ENTERPRISE DRIVE | PLAINSBORO | NJ | 08536 |
| K152897 | INTEGRA LIFESCIENCES CORPORATION |
311 ENTERPRISE DRIVE | PLAINSBORO | NJ | 08536 |
| K140722 | INTEGRA LIFESCIENCES CORPORATION |
22 TERRY AVENUE | BURLINGTON | MA | 01803 |
| K072929 | INTEGRA LIFESCIENCES CORPORATION |
311 ENTERPRISE DR. | PLAINSBORO | NJ | 08536 |
| K191684 | Integra Lifesciences Corporation |
311 Enterprise Drive | Plainsboro | NJ | 08536 |
| K062599 | INTEGRA LIFESCIENCES CORPORATION |
311 ENTERPRISE DR. | PLAINSBORO | NJ | 08540 |
| K093968 | INTEGRA LIFESCIENCES CORPORATION |
311 ENTERPRISE DR. | PLAINSBORO | NJ | 08536 |
| K233445 | Integra LifeSciences Production Corporation |
11 Cabot Boulevard | Mansfield | MA | 02048 |
| K233448 | Integra LifeSciences Production Corporation |
11 Cabot Boulevard | Mansfield | MA | 02048 |
| K223330 | Integra LifeSciences Production Corporation |
11 Cabot Boulevard | Mansfield | MA | 02048 |
| K221840 | Integra LifeSciences Production Corporation |
11 Cabot Boulevard | Mansfield | MA | 02048 |
| K981246 | INTEGRA NEUROCARE LLC. |
8401 102ND ST. | PLEASANT PRAIRIE | WI | 53150-0390 |
| K971617 | INTEGRA NEUROCARE LLC. |
8401 102ND ST. | PLEASANT PRAIRIE | WI | 53150-0390 |
| K972994 | INTEGRA NEUROCARE LLC. |
8401 102ND ST. | PLEASANT PRAIRIE | WI | 53150-0390 |
| K970658 | INTEGRA NEUROCARE LLC. |
8401 102ND ST. | PLEASANT PRAIRIE | WI | 53150-0390 |
| K973525 | INTEGRA NEUROCARE LLC. |
8401 102ND ST. | PLEASANT PRAIRIE | WI | 53150-0390 |
| K961859 | INTEGRA NEUROCARE LLC. |
8401 102ND ST. | PLEASANT PRAIRIE | WI | 53150-0390 |
| K970983 | INTEGRA NEUROCARE LLC. |
8401 102ND ST. | PLEASANT PRAIRIE | WI | 53150-0390 |
| K963802 | INTEGRA NEUROCARE LLC. |
8401 102ND ST. | PLEASANT PRAIRIE | WI | 53150-0390 |
| K964371 | INTEGRA NEUROCARE LLC. |
8401 102ND ST. | PLEASANT PRAIRIE | WI | 53150-0390 |
| K022554 | INTEGRA NEUROSCIENCES |
311 ENTERPRISE DR. | PLAINSBORO | NJ | 08536 |
| K033698 | INTEGRA NEUROSCIENCES IMPLANTS S.A. |
311 ENTERPRISE DRIVE | PLAINSBORO | NJ | 08536 |
| K042558 | INTEGRA NEUROSCIENCES IMPLANTS S.A. |
311 ENTERPRISE DRIVE | PLAINSBORO | NJ | 08536 |
| K032817 | INTEGRA NEUROSCIENCES IMPLANTS S.A. |
311 ENTERPRISE DRIVE | PLAINSBORO | NJ | 08536 |
| K042192 | INTEGRA NEUROSCIENCES IMPLANTS S.A. |
311 ENTERPRISE DRIVE | PLAINSBORO | NJ | 08536 |
| K040201 | INTEGRA NEUROSCIENCES IMPLANTS S.A. |
311 ENTERPRISE DRIVE | PLAINSBORO | NJ | 08536 |
| K081773 | INTEGRA NEUROSCIENCES IMPLANTS S.A. |
311 ENTERPRISE DRIVE | PLAINSBORO | NJ | 08536 |
| K171880 | IRRAS Inc. |
7452 Herschel Avenue | La Jolla | CA | 92037 |
| K222471 | IRRAS USA |
11975 El Camino Real, Suite 304 | San Diego | CA | 92130 |
| K231664 | IRRAS USA Inc. |
11975 El Camino Real, Suite 304 | San Diego | CA | 92130 |
| K200807 | IRRAS USA Inc. |
11975 El Camino Real | San Diego | CA | 92130 |
| K192289 | IRRAS USA, Ltd. |
11975 El Camino Real, Suite 304 | San Diego | CA | 92130 |
| K221694 | JMED(Shenzhen) Technology Limited |
7#401, Zhongxing Road, Xiuxin Community, | Shenzhen City | 518122 | |
| K973774 | JOHNSON & JOHNSON PROFESSIONALS, INC. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767 |
| K964923 | JOHNSON & JOHNSON PROFESSIONALS, INC. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K980778 | JOHNSON & JOHNSON PROFESSIONALS, INC. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767 |
| K974739 | JOHNSON & JOHNSON PROFESSIONALS, INC. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767 |
| K992173 | JOHNSON & JOHNSON PROFESSIONALS, INC. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K002970 | MEDICAL DESIGNS L.L.C. |
213 SUNSET DR. | BRANDON | SD | 57005 |
| K042359 | MEDICAL DESIGNS, LLC |
1210 W. 18TH ST. | SIOUX FALLS | SD | 57104 |
| K152152 | Medos International Sarl |
Chemin-Blanc 38 | Le Locle | CH-2400 | |
| K143111 | MEDOS INTERNATIONAL SARL |
CHEMIN-BLANC 38 | LE LOCLE | 2400 | |
| K113526 | MEDOS INTERNATIONAL SARL |
325 Paramount Drive | Raynham | MA | 02767 |
| K112156 | MEDOS INTERNATIONAL SARL |
325 Paramount Drive | Raynham | MA | 02767 |
| K243676 | Medtronic Neurosurgery |
4620 N Beach Street | Fort Worth | TX | 76137 |
| K110560 | MEDTRONIC NEUROSURGERY |
125 CREMONA DR. | GOLETA | CA | 93117 |
| K052386 | MEDTRONIC NEUROSURGERY |
125 CREMONA DR. | GOLETA | CA | 93117 |
| K033850 | MEDTRONIC NEUROSURGERY |
125 CREMONA DR., | GOLETA | CA | 93117 |
| K060681 | MEDTRONIC NEUROSURGERY |
125 CREMONA DR. | GOLETA | CA | 93117 |
| K040943 | MEDTRONIC NEUROSURGERY |
125 CREMONA DR., | GOLETA | CA | 93117 |
| K123524 | MEDTRONIC NEUROSURGERY |
125 CREMONA DR. | GOLETA | CA | 93117 |
| K041992 | MEDTRONIC NEUROSURGERY |
125 CREMONA DR. | GOLETA | CA | 93117 |
| K042198 | MEDTRONIC NEUROSURGERY |
125 CREMONA DR. | GOLETA | CA | 93117 |
| K042465 | MEDTRONIC NEUROSURGERY |
125 CREMONA DR. | GOLETA | CA | 93117 |
| K091312 | MEDTRONIC NEUROSURGERY |
125 CREMONA DR. | GOLETA | CA | 93117 |
| K063836 | MEDTRONIC NEUROSURGERY |
125 CREMONA DR. | GOLETA | CA | 93117 |
| K073139 | MEDTRONIC NEUROSURGERY |
125 CREMONA DR. | GOLETA | CA | 93117 |
| K083076 | MEDTRONIC NEUROSURGERY |
125 CREMONA DR. | GOLETA | CA | 93117 |
| K082127 | MEDTRONIC NEUROSURGERY |
125 CREMONA DR. | GOLETA | CA | 93117 |
| K181622 | Medtronic Neurosurgery |
125 Cremona Dr | Goleta | CA | 93117 |
| K212641 | Medtronic Neurosurgery |
5290 California Avenue | Irvine | CA | 92617 |
| K152700 | MEDTRONIC NEUROSURGERY |
125 CREMONA DRIVE | GOLETA | CA | 93117 |
| K984053 | MEDTRONIC PS MEDICAL |
125 CREMONA DR. | GOLETA | CA | 93117-5500 |
| K981046 | MEDTRONIC PS MEDICAL |
125 CREMONA DR. | GOLETA | CA | 93117-5500 |
| K991502 | MEDTRONIC PS MEDICAL |
125 CREMONA DR. | GOLETA | CA | 93117-5500 |
| K012052 | MEDTRONIC PS MEDICAL |
125 CREMONA DR. | GOLETA | CA | 93117-5500 |
| K150898 | MOLLER MEDICAL GMBH |
WASSERKUPPENSTR.29-31 | FULDA | 36043 | |
| K121248 | MOLLER MEDICAL GMBH |
1612 JENKS DRIVE | CORONA | CA | 92880 |
| K080168 | NEURO DIAGNOSTIC DEVICES |
ONE NESHAMAMINY INTERPLEX | TREVOSE | PA | 19053 |
| K974708 | NEUROCARE GROUP |
8401 102ND STREET, SUITE 200 | PLEASANT PRAIRIE | WI | 53158-0390 |
| K123554 | NEURODX DEVELOPMENT LLC |
3333 Street Rd | Bensalem | PA | 19020 |
| K021196 | NEURON THERAPEUTICS, INC. |
81 GREAT VALLEY PKWY. | MALVERN | PA | 19355 |
| K990660 | NMT NEUROSCIENCES IMPLANTS S.A. |
6011 CELLINI ST. | CORAL GABLES | FL | 33146 |
| K243205 | Phasor Health, LLC |
8944 Kirby Drive | Houston | TX | 77054 |
| K033017 | PHOENIX BIOMEDICAL |
PO BOX 80390 | VALLEY FORGE | PA | 19484 |
| K024040 | PHOENIX BIOMEDICAL CORP. |
2495 GENERAL ARMISTEAD AVE. | NORRISTOWN | PA | 19403 |
| K030468 | PHOENIX BIOMEDICAL CORP. |
2495 GENERAL ARMISTEAD AVE. | VALLEY FORGE | PA | 19484 |
| K974096 | PHOENIX BIOMEDICAL CORP. |
2495 GENERAL ARMSTEAD AVE. | NORRISTOWN | PA | 19403 |
| K990256 | PHOENIX BIOMEDICAL CORP. |
2495 GENERAL ARMSTEAD AVE. | NORRISTOWN | PA | 19403 |
| K991429 | PHOENIX BIOMEDICAL CORP. |
2495 GENERAL ARMSTEAD AVE. | NORRISTOWN | PA | 19403 |
| K002476 | PHOENIX BIOMEDICAL CORP. |
2495 GENERAL ARMISTEAD AVE. | VALLEY FORGE | PA | 19484 |
| K021644 | PHOENIX BIOMEDICAL CORP. |
2495 GENERAL ARMISTEAD AVE. | VALLEY FORGE | PA | 19484 |
| K960435 | PHOENIX BIOMEDICAL CORP. |
2495 GENERAL ARMSTEAD AVE. | VALLEY FORGE | PA | 19484 |
| K024101 | PHOENIX BIOMEDICAL CORP. |
2495 GENERAL ARMSTEAD AVE. | NORRISTOWN | PA | 19403 |
| K000514 | PHOENIX BIOMEDICAL CORP. |
2495 GENERAL ARMSTEAD AVE. | VALLEY FORGE | PA | 19484 |
| K954285 | RADIONICS, INC. |
76 CAMBRIDGE ST. | BURLINGTON | MA | 01803 |
| K970578 | RADIONICS, INC. |
22 TERRY AVE. | BURLINGTON | MA | 01803-2516 |
| K964386 | RADIONICS, INC. |
22 TERRY AVE. | BURLINGTON | MA | 01803-2516 |
| K971511 | RADIONICS, INC. |
76 CAMBRIDGE ST. | BURLINGTON | MA | 01803 |
| K980903 | RADIONICS, INC. |
22 TERRY AVE. | BURLINGTON | MA | 01803-2516 |
| K000057 | RADIONICS, INC. |
22 TERRY AVE. | BURLINGTON | MA | 01803-2516 |
| K962990 | RADIONICS, INC. |
22 TERRY AVE. | BURLINGTON | MA | 01803-2516 |
| K992379 | RADIONICS, INC. |
22 TERRY AVE. | BURLINGTON | MA | 01803-2516 |
| K992226 | RADIONICS, INC. |
22 TERRY AVE. | BURLINGTON | MA | 01803-2516 |
| K040021 | SAMUEL NEFF M.D. |
17 WHITE HORSE PIKE | HADDON HEIGHTS | NJ | 08035-1299 |
| K242974 | Sophysa |
5 Rue Guy Moquet | Orsay | 91400 | |
| K222422 | Sophysa |
05 Rue Guy Moquet | Orsay | 91400 | |
| K031097 | SOPHYSA SA |
70 WALNUT ST. | WELLESLEY | MA | 02481 |
| K042481 | SOPHYSA SA |
70 WALNUT ST. | WELLESLEY | MA | 02481 |
| K141227 | SOPHYSA SA |
25108 MARGUERITE PARKWAY, SUITE A-354 | MISSION VIEJO | CA | 92692 |
| K090342 | SOPHYSA SA |
2884 DANAPOPLAR | DANA POINT | CA | 92629 |
| K091328 | SOPHYSA SA |
8502 E. CHAPMAN AVE | ORANGE | CA | 92869 |
| K013488 | SOPHYSA SA |
70 WALNUT ST. | WELLESLEY | MA | 02481 |
| K992465 | SOPHYSA SA |
70 WALNUT ST. | WELLESLEY | MA | 02481 |
| K081942 | VYGON NEURO |
2495 GENERAL ARMISTEAD AVE. | NORRISTOWN | PA | 19403 |
| K033704 | VYGON US LLC |
2495 GENERAL ARMSTEAD AVE. | NORRISTOWN | PA | 19403 |
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