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 |
|---|---|---|---|---|---|
| K240253 | Aerin Medical Inc. |
2565 Leghorn St. | Mountain View | CA | 94043 |
| 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 | |
| K241954 | PAJUNK GmbH Medizintechnologie |
Karl-Hall-Str. 1 | Geisingen | 78187 | |
| K243690 | PAJUNK GmbH Medizintechnologie |
Karl-Hall-Str. 1 | Geisingen | 78187 | |
| K243682 | PAJUNK GmbH Medizintechnologie |
Karl-Hall-Str. 1 | Geisingen | 78187 | |
| K243525 | PAJUNK GmbH Medizintechnologie |
Karl-Hall-Str. 1 | Geisingen | 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 | |
| K241953 | PAJUNK GmbH Medizintechnologie |
Karl-Hall-Str. 1 | Geisingen | 78187 | |
| K250774 | 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 |
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