FDA 510(k) Applications for Medical Device:
Catheter, Urological
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K220730 | Allwin Medical Devices, Inc |
3305 E. Miraloma Avenue, Suite 176 | Anaheim | CA | 92806 |
| K032710 | APOGEE MEDICAL, INC. |
90 WEATHERS ST. | YOUNGSVILLE | NC | 27596 |
| K011965 | BOSTON SCIENTIFIC CORP. |
One Boston Scientific Place | Natick | MA | 01760 |
| K965229 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. | NATICK | MA | 01760-1537 |
| K022135 | BOSTON SCIENTIFIC CORP. |
One Boston Scientific Place | Natick | MA | 01760 |
| K180530 | Boston Scientific Corporation |
100 Boston Scientific Way | Marlborough | MA | 01752 |
| K102527 | Boston Scientific Corporation |
100 BOSTON SCIENTIFIC WAY | MARLBOROUGH | MA | 01752 |
| K033719 | C.R. BARD, INC. |
8195 INDUSTRIAL BLVD. | COVINGTON | GA | 30014 |
| K161344 | CONVATEC LIMITED |
GDC, FIRST AVENUE, DEESIDE INDUSTRIAL PARK | DEESIDE | CH5 2NU | |
| K172924 | ConvaTec Limited |
ConvaTec Limited (GDC) | Deeside | CH5 2NU | |
| K140953 | CONVATEC LTD. |
UNIT 20, FIRST AVENUE, DEESIDE INDUSTRIAL PARK | DEESIDE | CH5 2NU | |
| K181144 | Cook Incorporated |
750 Daniels Way | Bloomington | IN | 47404 |
| K171810 | Cook Incorporated |
750 Daniels Way | Bloomington | IN | 47402 |
| K171662 | Cook Incorporated |
750 Daniels Way | Bloomington | IN | 47402 |
| K171600 | Cook Incorporated |
750 Daniels Way | Bloomington | IN | 47404 |
| K080881 | CURE MEDICAL LLC. |
29442 POINTE ROYAL | LAGUNA NIGUEL | CA | 92677 |
| K002396 | ENDOCARE, INC. |
7 STUDEBAKER | IRVINE | CA | 92618 |
| K010339 | ENDOCARE, INC. |
7 STUDEBAKER | IRVINE | CA | 92618 |
| K013483 | HOLLISTER, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K013345 | HOLLISTER, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K001583 | ISLAND BIOSURGICAL, LLC. |
18 MEADOW LN. | MERCER ISLAND | WA | 98040-5340 |
| K080878 | MEDICAL TECHNOLOGIES OF GEORGIA, INC. |
15151 PRATER DRIVE | COVINGTON | GA | 30014 |
| K183335 | Medline Industries, Inc. |
Three Lakes Drive | Northfield | IL | 60093 |
| K103349 | PLUROMED, INC. |
25-H OLYMPIA AVENUE | WOBURN | MA | 01801 |
| K110491 | PLUROMED, INC. |
25-H OLYMPIA AVENUE | WOBURN | MA | 01801 |
| K090270 | PLUROMED, INC. |
25-H OLYMPIA AVENUE | WOBURN | MA | 01801 |
| K160877 | ROBLING MEDICAL, INC. |
90 Weathers Street | Youngsville | NC | 27596 |
| K000723 | ROCHESTER MEDICAL CORP. |
ONE ROCHESTER MEDICAL DR. | STEWARTVILLE | MN | 55976 |
| K000070 | RUSCH INTL. |
TALL PINES PARK | JAFFREY | NH | 03452 |
| K033023 | RUSCH INTL. |
50 PLANTATION DR. | JAFFERY | NH | 03452 |
| K181979 | Teleflex Medical, Inc. |
3015 Carrington Mill Blvd, Suite 600 North | Morrisville | NC | 27560 |
| K041243 | TYCO HEALTHCARE |
15 HAMPSHIRE ST. | MANSFIELD | MA | 02048 |
| K040897 | TYCO HEALTHCARE |
15 HAMPSHIRE ST. | MANSFIELD | MA | 02048 |
| K211032 | UroGen Pharma Ltd |
9 Ha'Ta'asiya Street | Ra'anana | 4365405 | |
| K180354 | UroGen Pharma Ltd. |
9 Ha`Ta`asiya Street | RaÆanana | 4365007 | |
| K220036 | Well Lead Medical Co., Ltd. |
No.47, Guomao Avenue South, Hualong, Panyu | Guangzhou | 511434 |
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