FDA 510(k) Applications for Medical Device:
Insufflator, Hysteroscopic
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K971492 | BEI MEDICAL SYSTEMS CO., INC. |
83 HOBART ST. | HACKENSACK | NJ | 07601 |
| K011876 | CIRCON VIDEO |
492 OLD CONNECTICUT PATH | FRAMINGHAM | MA | 01701-4584 |
| K031213 | DAVOL, INC. |
SUBSIDIARY OF C.R. BARD | CRANSTON | RI | 02920 |
| K011069 | DAVOL, INC., SUB. C.R. BARD, INC. |
100 SOCKANOSSETT CROSSROAD | CRANSTON | RI | 02920 |
| K991799 | DAVOL, INC., SUB. C.R. BARD, INC. |
100 SOCKANOSSETT CROSSROAD | CRANSTON | RI | 02920 |
| K982867 | DAVOL, INC., SUB. C.R. BARD, INC. |
100 SOCKANOSSETT CROSSROAD | CRANSTON | RI | 02920 |
| K970078 | DAVOL, INC., SUB. C.R. BARD, INC. |
100 SOCKANOSSETT CROSSROAD | CRANSTON | RI | 02920 |
| K110852 | GYRUS ACMI, INC. |
136 TURNPIKE RD. | SOUTHBOROUGH | MA | 01772 |
| K180825 | Hologic, Inc. |
250 Campus Drive | Marlborough | MA | 01752 |
| K240886 | Hologic, Inc. |
250 Campus Drive | Marlborough | MA | 01752 |
| K000806 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K961091 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K180735 | Karl Storz SE & Co. KG |
Dr.-Karl-Storz-StraBe 34 | Tuttlingen | 78532 | |
| K201355 | Karl Storz SE & Co. KG |
Dr.-Karl-Storz-Strasse 34 | Tuttlingen | 78532 | |
| K964136 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
353 CORPORATE WOODS PKWY. | VERNON HILLS | IL | 60061 |
| K133799 | THERMEDX LLC |
31200 SOLON RD., UNIT #1 | SOLON | OH | 44139 |
| K172048 | THERMEDX, LLC |
31200 Solon Rd., Unit #1 | Solon | OH | 44139 |
| K091939 | THERMEDX, LLC |
31200 SOLON ROAD | SOLON | OH | 44139 |
| K210628 | Thermedx, LLC |
31200 Solon Rd Unit 1 | Solon | OH | 44139 |
| K112642 | W.O.M. WORLD OF MEDICINE AG |
1480 CAMBRIDGE STREET | CAMBRIDGE | MA | 02139 |
| K022449 | W.O.M. WORLD OF MEDICINE AG |
91 TROWBRIDGE ST. | CAMBRIDGE | MA | 02138 |
| K123732 | W.O.M. WORLD OF MEDICINE AG |
1480 CAMBRIDGE STREET | CAMBRIDGE | MA | 02139 |
| K031616 | W.O.M. WORLD OF MEDICINE AG |
320 NORTH COLUMBUS ST. | ALEXANDRIA | VA | 22314 |
| K172040 | W.O.M. World Of Medicine GmbH |
Salzufer 8 | Berlin | 10587 | |
| K173489 | W.O.M. World of Medicine GmbH |
Salzufer 8 | Berlin | 10587 | |
| K983889 | W.O.M. WORLD OF MEDICINE, GMBH |
194 BRANCH ST. | MANSFIELD | MA | 02048 |
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