FDA 510(k) Applications for Medical Device:
Tube Tracheostomy And Tube Cuff
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K123699 | ANDREAS FAHL MEDIZINTECHNIK-VERTRIEB GMBH |
AUGUST-HORCH-STR. 4A | KOELN | 51149 | |
| K151404 | ATOS MEDICAL AB |
KRAFTGATAN 8 | HORBY | SE-242 22 | |
| K014102 | ATOS MEDICAL AB |
KRAFTGATAN 8 | HORBY | SE-242 22 | |
| K072582 | ATOS MEDICAL AB |
24301 WOODSAGE DRIVE | BONITA SPRINGS | FL | 34134 |
| K973829 | AUTOMATIC LIQUID PACKAGING, INC. |
2200 W. LAKE SHORE DR. | WOODSTOCK | IL | 60098 |
| K000964 | AUTOMATIC LIQUID PACKAGING, INC. |
2200 LAKE SHORE DR. | WOODSTOCK | IL | 60098 |
| K962078 | CONTINENTAL MEDICAL LABORATORIES, INC. |
817 W.MOHR AVE. | WATERFORD | WI | 53185 |
| K193133 | Cook Incorporated |
750 Daniels Way | Bloomington | IN | 47404 |
| K180034 | Cook Incorporated |
750 Daniels Way, P.O. Box 489 | Bloomington | IN | 47404 |
| K072148 | COOK, INC. |
750 DANIELS WAY | BLOOMINGTON | IN | 47404 |
| K093469 | COOK, INC. |
750 DANIELS WAY | BLOOMINGTON | IN | 47402-0489 |
| K041044 | COOK, INC. |
750 DANIELS WAY | BLOOMINGTON | IN | 47402-0489 |
| K133597 | COOK, INC. |
750 DANIELS WAY | BLOOMINGTON | IN | 47404 |
| K193077 | Covidien |
6135 Gunbarrel Ave | Boulder | CO | 80301 |
| K142296 | Covidien |
6135 Gunbarrel Ave | Boulder | CO | 80301 |
| K150844 | COVIDIEN |
6135 GUNBARREL AVE | BOULDER | CO | 80301 |
| K122531 | COVIDIEN |
6135 GUNBARREL AVE. | BOULDER | CO | 80021 |
| K142298 | Covidien |
6135 Gunbarrel Avenue | Boulder | CO | 80301 |
| K182861 | Covidien |
6135 Gunbarrel Ave | Boulder | CO | 80301 |
| K013728 | ENGINEERED MEDICAL SYSTEMS |
6329 W. WATERVIEW CT. | MCCORDSVILLE | IN | 46055 |
| K122932 | FOGLESS INTERNATIONAL AB |
STORGATAN 24 | VAGGERYD | 56732 | |
| K133528 | H&H MEDICAL CORPORATION |
290 TURNPIKE RD. | WESTBOROUGH | MA | 01581 |
| K954749 | MALLINCKRODT MEDICAL |
675 MCDONNELL BLVD. | ST. LOUIS | MO | 63134 |
| K963732 | MALLINCKRODT MEDICAL |
675 MCDONNELL BLVD. | ST. LOUIS | MO | 63134 |
| K962173 | MALLINCKRODT MEDICAL |
675 MCDONNELL BLVD. | ST. LOUIS | MO | 63134 |
| K955680 | MALLINCKRODT MEDICAL |
675 MCDONNELL BLVD. | ST. LOUIS | MO | 63134 |
| K971267 | MALLINCKRODT MEDICAL |
675 MCDONNELL BLVD. | ST. LOUIS | MO | 63134 |
| K051416 | MALLINCKRODT MEDICAL |
4280 HACIENDA DRIVE | PLEASANTON | CA | 94588 |
| K003315 | MALLINCKRODT, INC. |
3 MISSOURI RESEARCH PARK DR. | ST. CHARLES | MO | 63304 |
| K041485 | MARPAC, INC. |
8436 WASHINGTON PL. N.E. | ALBUQUERQUE | NM | 87113 |
| K022212 | MENTOR MEDICAL LIMITED |
MILITARY ROAD | HYTHE, KENT | CT21 6DB | |
| K030787 | NELLCOR PURITAN BENNETT, INC. |
4280 HACIENDA DR. | PLEASANTON | CA | 94588-2719 |
| K962714 | PASSY-MUIR, INC. |
4521 CAMPUS DR., SUITE 273 | IRVINE | CA | 92612 |
| K990905 | PASSY-MUIR, INC. |
4521 CAMPUS DR., SUITE 273 | IRVINE | CA | 92612 |
| K970365 | PASSY-MUIR, INC. |
4521 CAMPUS DR., SUITE 273 | IRVINE | CA | 92612 |
| K982128 | PILLING WECK SURGICAL |
420 DELAWARE DR. | FORT WASHINGTON | PA | 19034 |
| K970811 | PNEUMOCARE, INC. |
23991 IRONHEAD LN. | LAGUNA NIGUEL | CA | 92677 |
| K040014 | PORTEX LTD. |
MILITARY ROAD | HYTHE, KENT | CT21 6DB | |
| K031057 | PORTEX, INC. |
10 BOWMAN DR. | KEENE | NH | 03431 |
| K023918 | RUSCH INTL. |
50 PLANTATION DR. | JAFFERY | NH | 03452 |
| K972546 | RUSCH INTL. |
TALL PINES PARK | JAFFREY | NH | 03452 |
| K972423 | RUSCH INTL. |
TALL PINES PARK | JAFFREY | NH | 03452 |
| K964056 | RUSCH INTL. |
TALL PINES PARK | JAFFREY | NH | 03452 |
| K011210 | RUSCH INTL. |
50 PLANTATION DR. | JAFFERY | NH | 03452 |
| K955564 | RUSCH, INC. |
TALL PINES PARK | JAFFREY | NH | 03452 |
| K100995 | SHIKANI MEDICAL, LLC |
24301 WOODSAGE DRIVE | BONITA SPRINGS | FL | 34134 |
| K980466 | SIMS PORTEX, INC. |
10 BOWMAN DR. | KEENE | NH | 03431 |
| K972385 | SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. |
15 KIT ST. | KEENE | NH | 03431 |
| K960429 | SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. |
15 KIT ST. | KEENE | NH | 03431 |
| K962175 | SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. |
15 KIT ST. | KEENE | NH | 03431 |
| K041348 | SMITHS MEDICAL |
MILITARY ROAD | HYTHE, KENT | CT 21 5BN | |
| K081440 | SMITHS MEDICAL ASD, INC. |
6250 SHIER RINGS RD. | DUBLIN | OH | 43016 |
| K083641 | SMITHS MEDICAL ASD, INC. |
5700 WEST 23RD AVE. | GARY | IN | 46406 |
| K173912 | Smiths Medical ASD, Inc. |
6000 Nathan Lane North | Minneapolis | MN | 55442 |
| K170720 | Smiths Medical ASD, Inc. |
6000 Nathan Lane North | Minneapolis | MN | 55442 |
| K210833 | Smiths Medical ASD, Inc. |
6000 Nathan Lane North | Minneapolis | MN | 55442 |
| K133173 | Teleflex Medical, Inc. |
2917 WECK DR. | RESEARCH TRIANGLE PARK | NC | 27709 |
| K122235 | Teleflex Medical, Inc. |
2917 WECK DR. | RESEARCH TRIANGLE PARK | NC | 27709 |
| K961449 | TRACOE MEDICAL GMBH |
REICHSFORSTSTR. 32 | FRANKFURT/M | D-60528 | |
| K043160 | TRACOE MEDICAL GMBH |
117 FLANDERS ROAD | WESTBOROUGH | MA | 01581 |
| K172720 | TRACOE medical GmbH |
Reichelsheimer Str. 1/3 | Nieder-Olm | 55268 | |
| K203362 | TRACOE medical GmbH |
Reichelsheimer Str. 1/3 | Nieder-Olm | 55268 | |
| K954661 | ZIPPER MEDICAL, INC. |
10109 DAY AVE. | SILVER SPRING | MD | 20910-1041 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
