FDA 510(k) Applications for Medical Device:
Needle, Conduction, Anesthetic (W/Wo Introducer)
FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
K191290 |
Ancora Medical Technology |
333 Ravenswood Ave
| Menlo Park |
CA |
94025 |
K972595 |
AVID N.I.T., INC. |
917 KLOSTERMAN RD. EAST
| TARPON SPRINGS |
FL |
34689 |
K013231 |
AVID N.I.T., INC. |
390 SCARLET BLVD.
| OLDSMAR |
FL |
34677 |
K121846 |
B. BRAUN MEDICAL, INC. |
901 MARCON BLVD.
| ALLENTOWN |
PA |
18109-9341 |
K100241 |
B. BRAUN MEDICAL, INC. |
901 MARCON BLVD.
| ALLENTOWN |
PA |
18109-9341 |
K112515 |
B. BRAUN MEDICAL, INC. |
901 MARCON BLVD.
| ALLENTOWN |
PA |
18109-9341 |
K013610 |
B. BRAUN MEDICAL, INC. |
901 MARCON BLVD.
| ALLENTOWN |
PA |
18109-9341 |
K133632 |
B.BRAUN MEDICAL, INC |
901 MARCON BLVD
| ALLENTOWN |
PA |
18109-4962 |
K000495 |
BALLARD MEDICAL PRODUCTS |
12050 LONE PEAK PKWY.
| DRAPER |
UT |
84020 |
K013892 |
BALLARD MEDICAL PRODUCTS |
12050 LONE PEAK PKWY.
| DRAPER |
UT |
84020 |
K081446 |
BECTON DICKINSON & CO. |
1 Becton Drive
| Franklin Lakes |
NJ |
07417 |
K091758 |
BECTON DICKSON & CO. |
1 BECTON DR.
| FRANKLIN LAKES |
NJ |
07417-1880 |
K211085 |
Becton, Dickinson and Company |
1 Becton Drive
| Franklin Lakes |
NJ |
07417 |
K210978 |
Becton, Dickinson and Company |
1 Becton Drive
| Franklin Lakes |
NJ |
07417 |
K193131 |
Becton, Dickinson and Company |
1 Becton Drive
| Franklin Lakes |
NJ |
07417 |
K073222 |
BUSSE HOSPITAL DISPOSABLES, INC. |
75 ARKAY DRIVE
| HAUPPAUGE |
NY |
11788 |
K061394 |
BUSSE HOSPITAL DISPOSABLES, INC. |
75 ARKAY DRIVE
| HAUPPAUGE |
NY |
11788 |
K163216 |
C.R. Bard, Inc. |
605 North 5600 West
| Salt Lake City |
UT |
84116 |
K173155 |
Cook Incorporated |
750 Daniels Way
| Bloomington |
IN |
47404 |
K093209 |
COOK, INC. |
750 DANIELS WAY
| BLOOMINGTON |
IN |
47402 |
K101728 |
COOK, INC. |
750 DANIELS WAY
| BLOOMINGTON |
IN |
47402 |
K951928 |
CSEN LTD. |
P.O. BOX 27476
| ISRAEL |
|
|
K212328 |
DiscCath LLC |
62 E 88th Street
| New York |
NY |
10128 |
K183316 |
Dr. Japan Co., Ltd. |
1-1 Kagurazaka, Shinjuku-ku
| Tokyo |
|
162-0825 |
K163435 |
Entellus Medical Inc. |
3600 Holly Lane North, Suite 40
| Plymouth |
MN |
55447 |
K072005 |
EPIMED INTERNATIONAL |
141 SAL LANDRIO DR.
| JOHNSTOWN |
NY |
12095 |
K043467 |
EPIMED INTERNATIONAL, INC. |
141 SAL LANDRIO DR.
| JOHNSTOWN |
NY |
12095 |
K041843 |
EPIMED INTERNATIONAL, INC. |
141 SAL LANDRIO DR.
| JOHNSTOWN |
NY |
12095 |
K022029 |
EPIMED INTERNATIONAL, INC. |
141 SAL LANDRIO DR.
| JOHNSTOWN |
NY |
12095 |
K053318 |
EPIMED INTERNATIONAL, INC. |
141 SAL LANDRIO DR.
| JOHNSTOWN |
NY |
12095 |
K030562 |
EPIMED INTERNATIONAL, INC. |
141 SAL LANDRIO DR.
| JOHNSTOWN |
NY |
12095 |
K961444 |
GLOBAL MEDICAL PRODUCTS, LTD. |
244 MAIN ST., SOUTH
| WOODBURY |
CT |
06798-0505 |
K212982 |
Global Medikit Limited |
Khasra No 323 MI, Camp Road, Selaqui,
| Dehradun |
|
248197 |
K961151 |
HAKKO SHOJI CO., LTD. |
3726 LONSDALE AVE.
| CINCINNATI |
OH |
45227 |
K961152 |
HAKKO SHOJI CO., LTD. |
3726 LONSDALE AVE.
| CINCINNATI |
OH |
45227 |
K063380 |
HAVEL'S, INC. |
3726 LONSDALE ST.
| CINCINNATI |
OH |
45227 |
K043500 |
INNOSPINE, INC. |
11240 MAGDALENA ROAD
| LOS ALTOS HILLS |
CA |
94024 |
K070354 |
INTERNATIONAL MEDICAL DEVELOPMENT, INC |
9202 KELLEY DRIVE
| HUNTSVILLE |
UT |
84317 |
K170112 |
INTERNATIONAL MEDICAL DEVELOPMENT, INC.(IMD) |
560 HIGHWAY 39 (PO BOX 510)
| HUNTSVILLE |
UT |
84317 |
K032981 |
INVAMED TECHNOLOGIES INC. |
9955 TITAN PARK CIRCLE
| LITTLETON |
CO |
80125 |
K962886 |
ISPG, INC. |
517 LITCHFIELD RD.
| NEW MILFORD |
CT |
06776 |
K063071 |
KYPHON, INC. |
1221 CROSSMAN AVE.
| SUNNYVALE |
CA |
94089 |
K073516 |
KYPHON, INC. |
1221 CROSSMAN AVE.
| SUNNYVALE |
CA |
94089 |
K061210 |
KYPHON, INC. |
1221 CROSSMAN AVE.
| SUNNYVALE |
CA |
94089 |
K080140 |
LAURIMED LLC |
500 ARGUELLO STREET, SUITE 100
| REDWOOD CITY |
CA |
94063 |
K091818 |
LAURIMED LLC |
500 ARGUELLO STREET, SUITE 100
| REDWOOD CITY |
CA |
94063 |
K083909 |
LAURIMED LLC |
500 ARGUELLO STREET, SUITE 100
| REDWOOD CITY |
CA |
94063 |
K131006 |
LCCS PRODUCTS LIMITED |
7TH FLOOR, JINGGUI BUSINESS BUILDING, NO. 982 CONGYUN RD.,
| GUANGZHOU, GUANGDONG |
|
510420 |
K050499 |
LIFE-TECH, INC. |
4235 GREENBRIAR DR.
| STAFFORD |
TX |
77477-3995 |
K081864 |
LIFE-TECH, INC. |
4235 GREENBRIAR DR.
| STAFFORD |
TX |
77477-3995 |
K082772 |
LIFE-TECH, INC. |
4235 GREENBRIAR DR.
| STAFFORD |
TX |
77477-3995 |
K980536 |
MANAN MEDICAL PRODUCTS, INC. |
2200 CARLSON DR.
| NORTHBROOK |
IL |
60062 |
K983620 |
MANAN MEDICAL PRODUCTS, INC. |
2200 CARLSON DR.
| NORTHBROOK |
IL |
60062 |
K011209 |
MANAN MEDICAL PRODUCTS, INC. |
241 W. PALATINE RD.
| WHEELING |
IL |
60090 |
K110194 |
MEDLINE, INDUSTRIES, INC. |
ONE MEDLINE PLACE
| MUNDELEIN |
IL |
60060 |
K990519 |
MYCO MEDICAL SUPPLIES, INC. |
101 ROSE VALLEY WOODS DR.
| CARY |
NC |
27513 |
K203668 |
MYCO Medical Supplies, Inc. |
2015 Production Drive
| Apex |
NC |
27539 |
K020934 |
MYCO MEDICAL, INC. |
113 CENTRE WEST COURT
| CARY |
NC |
27513 |
K023218 |
PAJUNK GMBH |
5010 NW CRESCENT VALLEY DR.
| CORVALLIS |
OR |
97330 |
K042979 |
PAJUNK GMBH |
5010 NW CRESCENT VALLEY DR.
| CORVALLIS |
OR |
97330 |
K040965 |
PAJUNK GMBH |
203 MAIN STREET, PMB 166
| FLEMINGTON, |
NJ |
08822 |
K113207 |
PAJUNK GMBH |
KARL-HALL-STRASSE 1
| GEISINGEN |
|
D-78187 |
K000722 |
PAJUNK GMBH |
5010 NW CRESCENT VALLEY DR.
| CORVALLIS |
OR |
97330 |
K063350 |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
KARL-HALL-STRASSE 01
| GEISINGEN, BADEN-WURTTEMBERG |
|
78187 |
K170435 |
PAJUNK GmbH Medizintechnologie |
Karl-Hall-Str. 1
| Geisingen |
|
78187 |
K111374 |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
KARL-HALL-STRASSE 01
| GEISINGEN, BADEN-WURTTEMBERG |
|
78187 |
K160295 |
PAJUNK GmbH Medizintechnologie |
Karl-Hall-Str. 1
| Geisingen |
|
78187 |
K160294 |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
KARL-HALL STR. 1
| GEISINGEN |
|
78187 |
K160296 |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
KARL-HALL STR. 1
| GEISINGEN |
|
78187 |
K160297 |
PAJUNK GmbH Medizintechnologie |
Karl-Hall-Str. 1
| Geisingen |
|
78187 |
K192914 |
Philips Medical Systems Nederland B.V. |
Veenpluis 4-6
| Best |
|
5684 PC |
K150266 |
REMINGTON MEDICAL, INC. |
6830 MEADOWRIDGE COURT
| ALPHARETTA |
GA |
30005 |
K011122 |
RUSCH INTL. |
50 PLANTATION DR.
| JAFFERY |
NH |
03452 |
K120475 |
SHANGHAI SA MEDICAL & PLASTIC INSTRUMENTS CO., LTD |
7TH FL, JINGUI BUSINESS BLDG.
| BAIYUM DISTRICT, GUANGZHOU |
|
510420 |
K993619 |
SIMS PORTEX, INC. |
10 BOWMAN DR.
| KEENE |
NH |
03431 |
K171968 |
Smiths Medical ASD, Inc. |
6000 Nathan Lane North
| Minneapolis |
MN |
55442 |
K172823 |
Smiths Medical ASD, Inc. |
6000 Nathan Lane North
| Minneapolis |
MN |
55442 |
K172410 |
Smiths Medical ASD, Inc. |
6000 Nathan Lane North
| Minneapolis |
MN |
55442 |
K090261 |
SMITHS MEDICAL ASD, INC. |
10 BOWMAN DR.
| KEENE |
NH |
03431 |
K151072 |
Solo-Dex, Inc. |
3 Moonlight Isle
| Ladera Ranch |
CA |
92694 |
K163292 |
SPECTRA MEDICAL DEVICES |
260-H FORDHAM ROAD
| WILMINGTON |
MA |
01887 |
K151069 |
SPECTRA MEDICAL DEVICES, INC. |
260 F/H Fordham Road
| WILMINGTON |
MA |
01887 |
K173110 |
Summit Medical Ltd. |
Bourton Industrial Park
| Bourton on the Water |
|
gl54 2hq |
K002405 |
TE ME NA S.A.R.L. |
3234 ELLA LN.
| NEW PORT RICHEY |
FL |
34655 |
K080603 |
TE ME NA SAS |
962 ALLEGRO LANE
| APOLLO BEACH |
FL |
33572 |
K190026 |
Teleflex Medical |
3015 Carrington Mill Blvd
| Morrisville |
NC |
27560 |
K173321 |
Teleflex Medical |
3015 Carrington Mill Blvd.
| Morrisville |
NC |
27560 |
K121812 |
UltraSonix Medical Corporation |
57 Lazy Brook Rd.
| Monroe |
CT |
06468 |
K142553 |
UNISIS CORP. |
2675-1, NISHIKATA
| KOSHIGAYA-SHI |
|
3430822 |
K141126 |
UNISIS CORP. |
1201 RICHARDSON DRIVE, SUITE 280
| RICHARDSON |
TX |
75080 |
K030618 |
WILSON-COOK MEDICAL, INC. |
4900 BETHANIA STATION RD.
| WINSTON-SALEM |
NC |
27105 |
K171518 |
Zhejiang kindly Medical Devices Co., Ltd |
No.758, 5th Binhai Road, Binhai Industrial Park
| Wenzhou |
|
325025 |
|
|