FDA 510(k) Applications for Medical Device:
Tube, Tracheal (W/Wo Connector)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K171411 | A.R Guide In Medical Ltd. |
13 Wadi El Haj | Nazareth | 17111 | |
| K110962 | AMBU A/S |
6740 BAYMEADOW DR. | GLEN BURNIE | MD | 21060 |
| K093186 | AMBU A/S |
6740 BAYMEADOW DR. | GLEN BURNIE | MD | 21060 |
| K981891 | AMBU, INC. |
611 NORTH HAMMONDS FERRY RD. | LINTHICUM | MD | 21090-1356 |
| K050785 | AMSINO INTERNATIONAL, INC. |
855 TOWNE CENTER DRIVE | POMONA | CA | 91767 |
| K060094 | ARCADIA MEDICAL CORPORATION |
1450 EAST AMERICAN LANE | SCHAUMBURG | IL | 60173 |
| K960450 | BOSTON MEDICAL PRODUCTS, INC. |
117 FLANDERS RD. | WESTBOROUGH | MA | 01581 |
| K213028 | Bryan Medical , Inc. |
5725 Dragon Way, Suite 300 | Cincinnati | OH | 45227 |
| K200761 | Bryan Medical, Inc. |
5725 Dragon Way, Suite 300 | Cincinnati | OH | 45227 |
| K071365 | C.R. BARD, INC. |
8195 INDUSTRIAL BLVD. | COVINGTON | GA | 30014 |
| K080170 | C.R. BARD, INC. |
8195 INDUSTRIAL BLVD. | COVINGTON | GA | 30014 |
| K030792 | C.R. BARD, INC. |
8195 INDUSTRIAL BLVD. | COVINGTON | GA | 30014 |
| K080105 | CHILECOM MEDICAL DEVICES CO., LTD. |
155 FLEMINGTON CT. | LA MIRADA | CA | 90638 |
| K082038 | CLARUS MEDICAL, LLC. |
1000 BOONE AVE. NORTH | MINNEAPOLIS | MN | 55427 |
| K171917 | Cook Incorporated |
750 Daniels Way, P.O. Box 489 | Bloomington | IN | 47404 |
| K151381 | Covidien |
6135 Gunbarrel Ave | Boulder | CO | 80301 |
| K223130 | Covidien |
6135 Gunbarrel Avenue | Boulder | CO | 80301 |
| K090352 | COVIDIEN |
6135 GUNBARREL AVE. | BOULDER | CO | 80516 |
| K233341 | Covidien LLC |
6135 Gunbarrel Avenue | Boulder | CO | 80301 |
| K141747 | DAVIS MEDICAL |
12602 N. SUMMER WIND DRIVE | MARANA | AZ | 85658 |
| K082420 | ETVIEW |
31 HAAVODA ST | BINYAMINA | 30500 | |
| K121028 | ETVIEW LTD. |
31 HAAVODA ST. | BINYAMINA | 30500 | |
| K152438 | ETVIEW LTD. |
M.P MISGAV | MISGAV BUSINESS PARK | 201790 | |
| K052233 | ETVIEW LTD. |
31 HAAVODA ST. | BINYAMINA | ||
| K181880 | ETView Ltd. |
M.P Misgav | Misgav Business Park | 2017900 | |
| K090777 | EZC MEDICAL, LLC |
16 A FUNSTON AVENUE | SAN FRANCISCO | CA | 94129 |
| K250243 | Flexicare Medical Limited |
Cynon Valley Business Park Mountain Ash. | Rhondda Cynon Taf | CF45 4ER | |
| K091591 | FLEXICARE MEDICAL LTD. |
CYNON VALLEY BUSINESS PARK | MID GLAMORGAN | CF45 4ER | |
| K971759 | GREEN FIELD MEDICAL SOURCING, INC. |
910 BOSTON TURNPIKE RD. | SHREWSBURY | MA | 01545 |
| K111401 | HANGZHOU BEVER MEDICAL DEVICES CO., LTD. |
NO. 8-1, LONGQUAN ROAD | HANGZHOU, ZHEJIANG | 311121 | |
| K111406 | HANGZHOU BEVER MEDICAL DEVICES CO., LTD. |
NO. 8-1, LONGQUAN ROAD | HANGZHOU, ZHEJIANG | 311121 | |
| K190213 | Jiangxi Yikang Medical Instrument Group Co., Ltd |
188 Aihua Road, Jinxian County | Nanchang | 331725 | |
| K120985 | KIMBERLY-CLARK CORP. |
1400 HOLCOMB BRIDGE RD. | ROSWELL | GA | 30076 |
| K131254 | KIMBERLY-CLARK CORP. |
1400 HOLCOMB BRIDGE RD. | ROSWELL | GA | 30076 |
| K080821 | KIMBERLY-CLARK CORP. |
1400 HOLCOMB BRIDGE RD. | ROSWELL | GA | 30076 |
| K113333 | KIMBERLY-CLARK CORPORATION |
1400 HOLCOMB BRIDGE RD. | ROSWELL | GA | 30076 |
| K962098 | KIRK SPECIALTY SYSTEMS |
1625 CRESCENT CIR., STE. 225 | CARROLLTON | TX | 75006 |
| K965132 | MALLINCKRODT MEDICAL |
675 MCDONNELL BLVD. | ST. LOUIS | MO | 63134 |
| K082520 | MALLINCKRODT MEDICAL |
6135 GUNBARREL AVE. | BOULDER | CO | 80301 |
| K080339 | MEDSOURCE INTERNATIONAL, LLC. |
11715 FOX ROAD | INDIANAPOLIS | IN | 46236 |
| K031794 | MERLYN ASSOCIATES INC. |
AMSINO INTERNATIONAL INC. | ONTARIO | CA | 91761 |
| K172208 | NeVap, Inc. |
975 Dionne Way | San Jose | CA | 95133 |
| K000045 | PARAPRODUCTS, INC. |
1431 INDUSTRIAL DR. | ITASCA | IL | 60143 |
| K984528 | PARKER MEDICAL ASSOC. |
109 INVERNESS DRIVE EAST, | ENGLEWOOD | CO | 80112-5105 |
| K100546 | PARKERMEDICALINC |
4655 KIRKWOOD COURT | BOULDER | CO | 80301 |
| K041917 | PLASIATEK, LLC |
10560 WAYZATA BLVD. | MINNEAPOLIS | MN | 55305 |
| K032112 | PORTEX LTD. |
MILITARY ROAD | ENGLAND CT21 6DB | ||
| K973191 | PULMONX |
1047 ELWELL COURT | PALO ALTO | CA | 94303 |
| K021540 | RUSCH INTL. |
TALL PINES PARK | JAFFREY | NH | 03452 |
| K023964 | RUSCH INTL. |
50 PLANTATION DR. | JAFFERY | NH | 03452 |
| K993786 | RUSCH INTL. |
TALL PINES PARK | JAFFREY | NH | 03452 |
| K961840 | RUSCH INTL. |
TALL PINES PARK | JAFFREY | NH | 03452 |
| K954585 | RUSCH INTL. |
TALL PINES PARK | JAFFREY | NH | 03452 |
| K990619 | RUSCH INTL. |
TALL PINES PARK | JAFFREY | NH | 03452 |
| K961837 | RUSCH INTL. |
TALL PINES PARK | JAFFREY | NH | 03452 |
| K955495 | RUSCH, INC. |
TALL PINES PARK | JAFFREY | NH | 03452 |
| K190878 | Salter Labs, Inc. |
2365 Camino Vida Roble | Carlsbad | CA | 92011 |
| K190630 | Securisyn Medical, LLC |
9150 Commerce Center Circle, Suite 135 | Highlands Ranch | CO | 80129 |
| K081086 | SMITHS MEDICAL ASD, INC. |
MILITARY ROAD | HYTHE, KENT | CT216JL | |
| K083119 | SMITHS MEDICAL ASD, INC. |
BOUNDARY ROAD | HYTHE, KENT | CT216JN | |
| K140228 | SUZHOU WEIKANG MEDICAL APPARATUS CO., LTD |
7TH FL. JINGUI BUSINESS BUIDLING NO. 982 | GUANGZHOU, GUANGDONG | 510420 | |
| K013321 | TECHNICAL PRODUCTS, INC. |
2416 PARK CENTRAL BLVD. | DECATUR | GA | 30035 |
| K241451 | Teleflex Incorporated |
3015 Carrington Mills Blvd | Morrisville | NC | 27560 |
| K242495 | Teleflex Medical |
3015 Carrington Mills Blvd | Morrisville | NC | 27560 |
| K043205 | TELEFLEX MEDICAL |
2345 WAUKEGAN ROAD | BANNOCKBURN | IL | 60015 |
| K150603 | Teleflex Medical, Inc. |
2917 Weck Drive | Research Triangle Park | NC | 27709 |
| K132415 | Teleflex Medical, Inc. |
2917 WECK DR. | RESEARCH TRIANGLE PARK | NC | 27709 |
| K141939 | Teleflex Medical, Inc. |
2917 WECK DR. | RESEARCH TRIANGLE PARK | NC | 27709 |
| K091761 | Teleflex Medical, Inc. |
2917 WECK DR. | RESEARCH TRIANGLE PARK | NC | 27709 |
| K192324 | TeleflexMedical, Inc |
3015 Carrington Mill Blvd , Suite 600 North | Morrisville | NC | 27560 |
| K991580 | THE LARYNGEAL MASK CO.,LTD. |
12300 TWINBROOK PKWY. | ROCKVILLE | MD | 20852 |
| K051993 | THE LARYNGEAL MASK CO.,LTD. |
9360 TOWNE CENTRE DR. | SAN DIEGO | CA | 92121 |
| K160694 | TIANJIN MEDIS MEDICAL DEVICE CO., LTD. |
10-A TIANZHI INDUSTRIAL CENTER, NO. 12 HONG YUAN ROAD | TIANJIN CITY | 300385 | |
| K190274 | Tianjin Medis Medical Device Co., Ltd. |
No. 15-A, Saida One Avenue, Xiqing Economic Development Area | Tainjin | 300385 | |
| K041311 | TIGER MEDICAL PRODUCTS LTD |
1308 MORNINGSIDE PARK DRIVE | ALPHARETTA | GA | 30022 |
| K962389 | UNOMEDICAL SDN BHD |
40178 U.S. 19 NORTH | TARPON SPRINGS | FL | 34689 |
| K093135 | VENNER MEDICAL (SINGAPORE) PTE LTD |
2626 VALLEY VIEW LANE, | DALLAS | TX | 75234 |
| K192120 | Venner Medical (Singapore) Pte Ltd |
35 Joo Koon Circle | Singapore | 629110 | |
| K990098 | VENTLAB CORP. |
PO BOX 4341 | CROFTON | MD | 21114-4341 |
| K050803 | VITAID, LTD. |
6329 W. WATERVIEW CT. | MCCORDSVILLE | IN | 46055-9501 |
| K970196 | VITAL SIGNS, INC. |
20 CAMPUS RD. | TOTOWA | NJ | 07512 |
| K960795 | VYGON CORP. |
1129 BLOOMFIELD AVE. | WEST CALDWELL | NJ | 07006 |
| K040657 | VYGON S A |
45900 PARSIPPANY COURT | TEMECULA | CA | 92592 |
| K110269 | WELL LEAD MEDICAL CO. LTD |
962 ALLEGRO LANE | APOLLO BEACH | FL | 33572 |
| K182739 | WELL LEAD MEDICAL CO., LTD. |
C-4 # Jinhu Industrial Estate, Hualong, Panyu | Guangzhou | 511434 | |
| K211543 | Well Lead Medical Co., LTD. |
C-4 Jinhu Industrial Estate Hualong, Panyu | Guangzhou | 511434 | |
| K042683 | WELL LEAD MEDICAL INSTRUMENTS |
962 ALLERGO LANE | APOLLO BEACH | FL | 33572 |
| K073383 | WELL LEAD MEDICAL INSTRUMENTS |
962 ALLERGO LANE | APOLLO BEACH | FL | 33572 |
| K161813 | WILLIAM COOK EUROPE APS |
SANDET 6 | BJAEVERSKOV | 4632 | |
| K251499 | William Cook Europe Aps |
Sandet 6 | Bjaeverskov | 4632 | |
| K990556 | WOLFE TORY MEDICAL, INC. |
79 WEST 4500 SOUTH, SUITE 21 | SALT LAKE CITY | UT | 84107 |
| K021044 | WOLFE TORY MEDICAL, INC. |
79 WEST 4500 SOUTH, SUITE 16 | SALT LAKE CITY | UT | 84107 |
| K993582 | XOMED, INC. |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216-0980 |
| K170234 | Zhanjiang Star Enterprise Co., Ltd |
NO.1, West Jinhua Rd. | Zhanjiang | 524094 |
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