FDA 510(k) Applications for Medical Device:
Catheter, Conduction, Anesthetic
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K000886 | ABBOTT LABORATORIES |
D-389, AP-30 | ABBOTT PARK | IL | 60064-3537 |
| K050557 | AMERICAN MEDICAL TECHNOLOGIES, INC. |
1211 WEST 13TH ST. | RIVIERA BEACH | FL | 33404 |
| K993592 | AXIOM MEDICAL, INC. |
555 WEST VICTORIA ST. | RANCHO DOMINGUEZ | CA | 90220 |
| K971851 | AXIOM MEDICAL, INC. |
555 WEST VICTORIA ST. | RANCHO DOMINGUEZ | CA | 90220 |
| K153297 | B. BRAUN MEDICAL INC |
901 MARCON BLVD. | ALLENTOWN | PA | 18109 |
| K171584 | B. Braun Medical Inc. |
901 Marcon Blvd. | Allentown | PA | 18109 |
| K231242 | B. Braun Medical Inc. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K042488 | B. BRAUN MEDICAL, INC. |
901 MARCON BLVD. | ALLENTOWN | PA | 18109-9341 |
| K022019 | B. BRAUN MEDICAL, INC. |
901 MARCON BLVD. | ALLENTOWN | PA | 18109 |
| K090884 | B. BRAUN MEDICAL, INC. |
901 MARCON BLVD. | ALLENTOWN | PA | 18109-9341 |
| K102594 | BAXANO, INC. |
655 RIVER OAKS PKWY | SAN JOSE | CA | 95134 |
| K093920 | BUSSE HOSPITAL DISPOSABLES |
75 ARKAY DRIVE | HAUPPAUGE | NY | 11788 |
| K070465 | BUSSE HOSPITAL DISPOSABLES, INC. |
P.O. BOX 11067 | HAUPPAUGE | NY | 11788 |
| K191470 | Cimpax ApS |
Lille Pilevang 4 | Slangerup | 3550 | |
| K951927 | CSEN LTD. |
P.O. BOX 27476 | ISRAEL | ||
| K023233 | EBI, L.P. |
399 JEFFERSON ROAD | PARSIPPANY | NJ | 07054 |
| K032390 | EBI, L.P. |
399 JEFFERSON ROAD | PARSIPPANY | NJ | 07054 |
| K200624 | Epimed International Inc. |
13958 Diplomat Drive | Farmers Branch | TX | 75234 |
| K981329 | EPIMED INTERNATIONAL, INC. |
P.O. BOX 1128 | GLOVERSVILLE | NY | 12078 |
| K133316 | EPIMED INTERNATIONAL, INC. |
141 SAL LANDRIO DR. | JOHNSTOWN | NY | 12095 |
| K023140 | EPIMED INTERNATIONAL, INC. |
141 SAL LANDRIO DR. | JOHNSTOWN | NY | 12095 |
| K171193 | Ferrosan Medical Devices SP. Z O.O. |
Koksowa 3 | Szczecin | 70-031 | |
| K161232 | HALYARD HEALTH |
5405 WINDWARD PARKWAY | ALPHARETTA | GA | 30004 |
| K193664 | HK Surgical |
1271 Puerto del Sol | San Clemente | CA | 92673 |
| K043456 | I-FLOW CORP. |
20202 WINDROW DR. | LAKE FOREST | CA | 92630 |
| K051401 | I-FLOW CORP. |
20202 WINDROW DR. | LAKE FOREST | CA | 92630 |
| K063234 | I-FLOW CORP. |
20202 WINDROW DR. | LAKE FOREST | CA | 92630 |
| K173541 | Imedicom Co., Ltd. |
#612, 172, LS-ro | Gunpo-si | 435824 | |
| K150789 | IMEDICOM CO., LTD. |
#612, 172, LS-ro | Gunpo-si | 435-824 | |
| K241410 | JMT Co., Ltd |
70-39, Gwonyul-ro 1203beon-gil, Baekseok-eup | Yangju-si | 11517 | |
| K143164 | KIMBERLY-CLARK CORPORATION |
43 DISCOVERY, SUITE 100 | IRVINE | CA | 92618 |
| K072050 | LIFE-TECH, INC. |
4235 GREENBRIAR DR. | STAFFORD | TX | 77477-3995 |
| K954584 | MEDIC EVALUATION DEVICES & INSTRUMENTS CORP. |
6 DIVISION ST., P.O. BOX 1128 | GLOVERSVILLE | NY | 12078 |
| K150731 | MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE | MUNDELEIN | IL | 60060 |
| K181782 | Medline Industries, Inc. |
Three Lakes Drive | Northfield | IL | 60093 |
| K001717 | MICOR, INC. |
2855 OXFORD BLVD. | ALLISON PARK | PA | 15101 |
| K991879 | MICOR, INC. |
2855 OXFORD BLVD. | ALLISON PARK | PA | 15101 |
| K172777 | PAJUNK GmbH Medizintechnologie |
Karl-Hall-Str. 1 | Geisingen | 78187 | |
| K152952 | PAJUNK GmbH Medizintechnologie |
Karl-Hall-Str. 1 | Geisingen | 78187 | |
| K080675 | PAJUNK GMBH MEDIZINTECHNOLOGIE |
KARL-HALL-STRASSE 01 | GEISINGEN, BADEN-WURTTEMBERG | 78187 | |
| K111031 | PLAN 1 HEALTH, S.R.L. |
2400 VIA CARILLO | PALOS VERDES ESTATES | CA | 90274 |
| K992471 | SIMS PORTEX, INC. |
10 BOWMAN DR. | KEENE | NH | 03431 |
| K051524 | SMITHS MEDICAL ASD, INC. |
10 BOWMAN DRIVE | KEENE | NH | 03431 |
| K062005 | SMITHS MEDICAL ASD, INC. |
10 BOWMAN DR. | KEENE | NH | 03431 |
| K081404 | SPINAL INTEGRATION LLC |
6314 KINGSPOINTE PKWY UNIT 6 | ORLANDO | FL | 32819 |
| K072702 | STRYKER INSTRUMENTS, INSTRUMENTS DIV. |
4100 EAST MILHAM AVE. | KALAMAZOO | MI | 49001 |
| K102460 | SUMMIT MEDICAL PRODUCTS, INC |
2480 SOUTH MAIN STREET | SALT LAKE CITY | UT | 84115 |
| K110814 | SUMMIT MEDICAL PRODUCTS, INC |
2480 SOUTH MAIN STREET | SALT LAKE CITY | UT | 84118 |
| K991259 | TE ME NA S.A.R.L. |
390 SCARLET BLVD. | OLDSMAR | FL | 34677 |
| K230603 | Teleflex Medical |
3015 Carrington Mill Blvd. | Morrisville | NC | 27560 |
| K162522 | TELEFLEX MEDICAL , INC. |
3015 Carrington Mill Blvd | Morrisville | NC | 27560 |
| K140110 | TELEFLEX, INC. |
2400 BERNVILLE ROAD | READING | PA | 19605 |
| K122661 | VITAL 5 |
570 RESEARCH PARK WAY | NORTH LOGAN | UT | 84341 |
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