FDA 510(k) Applications for Medical Device:
Insufflator, Hysteroscopic

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K881680 ACKRAD LABORATORIES 70 JACKSON DR.
CRANFORD NJ 07016
K842943 AXCAN SCIENTIFIC CORP.
K971492 BEI MEDICAL SYSTEMS CO., INC. 83 HOBART ST.
HACKENSACK NJ 07601
K901288 C.R. BARD, INC. 111 SPRING ST.
MURRAY HILL NJ 07974
K941743 CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST
LANGHORNE PA 19047
K873527 CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST
LANGHORNE PA 19047
K895907 CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST
LANGHORNE PA 19047
K905706 CIRCON ACMI 300 STILLWATER AVE.
STAMFORD CT 06904 1971
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
K933384 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
K892001 DEXIDE, INC. P.O. BOX 185789
FT. WORTH TX 76181
K911844 F.M. WIEST USA, INC. P.O. BOX 637
ORADEL NJ 07649
K921871 F.M. WIEST USA, INC. 690 KINDERKAMACK RD., 1ST FL.
ORADELL NJ 07649
K905495 FRIGITRONICS, INC. 1963 ROCK ST.
MOUNTAIN VIEW CA 94043
K110852 GYRUS ACMI, INC. 136 TURNPIKE RD.
SOUTHBOROUGH MA 01772
K180825 Hologic, Inc. 250 Campus Drive
Marlborough MA 01752
K936231 KARL STORZ ENDOSCOPY 600 CORPORATE POINTE
CULVER CITY CA 90230 7600
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
K950961 KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE
CULVER CITY CA 90230 7600
K912498 KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD.
CULVER CITY CA 90232 3578
K912789 LEISEGANG MEDICAL, INC. 6401 CONGRESS AVE.
BOCA RATON FL 33487 2883
K933873 LINVATEC CORP. 11311 CONCEPT BLVD.
LARGO FL 33773 4908
K872860 MEDLINE INDUSTRIES, INC. 99 INVERNESS DRIVE EAST
ENGLEWOOD CO 80112
K931606 NORTECH 3930 VENTURA DR.
ARLINGTON HEIGHTS IL 60004
K930912 NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR.
ARLINGTON HEIGHTS IL 60004
K922197 O.R. CONCEPTS, INC. 200 N. OAK ST.
ROANOKE TX 76262
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
K895659 UNIMAR, INC. 475 DANBURY RD.
WILTON CT 06897
K922632 W.O.M. GMBH PASCALSTRABE 11
BERLIN
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
K924523 W.O.M. WORLD OF MEDICINE, GMBH C/O QUALITIVITY
TUCSON AZ 85704 6508
K983889 W.O.M. WORLD OF MEDICINE, GMBH 194 BRANCH ST.
MANSFIELD MA 02048
K933847 W.O.M. WORLD OF MEDICINE, GMBH 1300 I STREET, N.W.
WASHIGNTON DC 20005 3306
K934866 W.O.M. WORLD OF MEDICINE, GMBH 1300 I STREET, N.W.
WASHIGNTON DC 20005 3306
K894259 WASHINGTON REGULATORY SERVICES R.D. # 3 BOX 237
RINGOES NJ 08551
K900908 ZIMMER, INC. 200 W. OHIO AVE.
DOVER OH 44622
K891028 ZINNANTI SURGICAL INSTRUMENTS, INC. 21540-B PRAIRIE ST.
CHATSWORTH CA 91311




Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact