FDA 510(k) Applications for Medical Device:
Accessory, Assisted Reproduction
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K991216 | (ARMS) HOFFMAN SURGICAL EQUIPMENT, IVF DIVISION |
555 NORTH LN. | CONSHOHOCKEN | PA | 19428 |
| K001600 |
170 FORT PATH RD. | MADISON | CT | 06443 | |
| K001486 |
170 FORT PATH RD. | MADISON | CT | 06443 | |
| K151357 | AT MEDICAL UAB |
DRAUGYSTES G.19 | KAUNAS | 51230 | |
| K133742 | AT MEDICAL UAB |
DRAUGYSTES G.19 | KAUNAS | 51230 | |
| K032526 | BINDER GMBH |
BERGSTRASSE 14 | TUTTLINGEN | D-78532 | |
| K983642 | COOK OB/GYN |
1100 WEST MORGAN ST. | SPENCER | IN | 47460 |
| K983609 | COOK OB/GYN |
1100 WEST MORGAN ST. | SPENCER | IN | 47460 |
| K992070 | COOK UROLOGICAL, INC. |
1100 WEST MORGAN ST. | SPENCER | IN | 47460 |
| K014160 | COOK UROLOGICAL, INC. |
1100 WEST MORGAN ST. | SPENCER | IN | 47460 |
| K002595 | CRYO BIO SYSTEM |
3722 AVE. SAUALITO | IRVINE | CA | 92606 |
| K171736 | Genea Biomedx Pty Ltd |
Level 2, 321 Kent Street | Sydney | 2000 | |
| K180304 | Genea Biomedx Pty Ltd |
Level 2, 321 Kent Street | Sydney | 2000 | |
| K180188 | Genea Biomedx Pty Ltd |
Level 2, 321 Kent Street | Sydney | 2000 | |
| K020560 | GENX INTL., INC. |
393 SOUNDVIEW RD. | GUILFORD | CT | 06437 |
| K991229 | HENNING KNUDSEN ENGINEERING A/S |
KLINTEHOJ VAENGE 1 | BIRKEROD | DK-3460 | |
| K013401 | K-SYSTEMS, KIVEX BIOTEC LTD. |
KLINTEHOJ VAENGE 21 | BIRKEROD | DA-3460 | |
| K023465 | KENDRO LABORATORY PRODUCTS, L.P. |
P.O. BOX 2156 | HUNTINGTON | CT | 06484 |
| K002805 | KENDRO LABORATORY PRODUCTS, L.P. |
55 NORTHERN BLVD.; SUITE 200 | GREAT NECK | NY | 11021 |
| K030525 | MID-ATLANTIC DIAGNOSTICS, INC. |
438 NORTH ELMWOOD RD. | MARLTON | NJ | 08053 |
| K050197 | MINITUBE OF AMERICA, INC |
ONE EAST MAIN STREET, STE 300 | MADISON | WI | 53703 |
| K132870 | ORIGIO, INC |
2400 HUNTERS WAY | CHARLOTTESVILLE | VA | 22911 |
| K032086 | PLANER PLC |
200 GREGORY LANE | PLEASANT HILL | CA | 94523-3389 |
| K121566 | PLANER PLC |
15696 OAKSTAND ROAD | POWAY | CA | 92064-3389 |
| K160504 | RESEARCH INSTRUMENTS LIMITED |
BICKLAND INDUSTRIAL PARK | FALMOUTH | TR11 4TA | |
| K000394 | ROCKET MEDICAL PLC |
WEAR IND. ESTATE DISTRICT 6 | WASHINGTON, TYNE & WEAR | NE37 1NE | |
| K013703 | SANYO NORTH AMERICA CORP. |
900 N. ARLINGTON HEIGHTS RD. | TASCA | IL | 60143-2844 |
| K101988 | SHANGHAI LISHEN SCIENTIFIC EQUIPMENT CO., LTD |
77325 JOYCE WAY | ECHO | OR | 97826 |
| K021042 | THERMO FORMA, INC. |
401 MILLCREEK RD. | MARIETTA | OH | 45750 |
| K001524 | THERMOQUEST CORP. |
MILL CREEK RD. | MARIETTA | OH | 45750 |
| K991408 | THERMOQUEST CORP. |
MILL CREEK RD. | MARIETTA | OH | 45750 |
| K991263 | TOKAI HIT CO., LTD. |
306-1 GENDOJI-CHO | FUJINOMIYA-SHI, SHIZUOKA-KEN | 418-0074 | |
| K113075 | UNISENSE FERTILITECH A/S |
TUEAGER 1 | ARRHUS N | DK-8200 | |
| K111715 | UNISENSE FERTILITECH A/S |
TUEAGER 1 | ARRHUS N | DK-8200 | |
| K092183 | UNISENSE FERTILITECH A/S |
BRENDSTRUPGARDSVEJ 21F | ARRHUS | DK-8200 | |
| K133712 | UNISENSE FERTILITECH A/S |
TUEAGER 1 | AARHUS N | DK-8200 | |
| K173264 | Vitrolife A/S |
Jens Juuls Vej 20 | Viby J | 8260 | |
| K160753 | WILLIAM A. COOK AUSTRALIA PTY LTD |
95 BRANDL STREET | Eight Mile Plains | 4113 | |
| K011327 | ZANDER MEDICAL SUPPLIES, INC. |
755 8TH CT., SUITE #4 | VERO BEACH | FL | 32962 |
| K002961 | ZANDER MEDICAL SUPPLIES, INC. |
755 8TH CT., SUITE #4 | VERO BEACH | FL | 32965-0790 |
| K002971 | ZANDER MEDICAL SUPPLIES, INC. |
755 8TH CT., SUITE #4 | VERO BEACH | FL | 32965-0790 |
| K003184 | ZANDER MEDICAL SUPPLIES, INC. |
755 8TH CT., SUITE #4 | VERO BEACH | FL | 32965-0790 |
| K041952 | ZANDER MEDICAL SUPPLIES, INC. |
755 8TH CT., SUITE #4 | VERO BEACH | FL | 32965-0790 |
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