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 |
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 |
|
|