FDA 510(k) Applications for Medical Device:
Probe, Radiofrequency Lesion

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K242841 Abbott Medical 6901 Preston Road
Plano TX 75024
K001588 ARTHROCARE CORP. 595 NORTH PASTORIA AVE.
SUNNYVALE CA 94085-2936
K203066 Avanos Medical, Inc. 5405 Windward Parkway, Suite 100
Alpharetta GA 30004
K053082 BAYLIS MEDICAL CO., INC. 2580 MATHESON BLVD. E
MISSISSAUGA, ONTARIO L4W 4J1
K002389 BAYLIS MEDICAL CO., INC. 5160 EXPLORER DRIVE, UNIT 5
MISSISSAUGA L4W-4T7
K071745 BAYLIS MEDICAL CO., INC. 2645 MATHESON BLVD. E
MISSISSAUGA, ONTARIO L4W 5S4
K972846 BAYLIS MEDICAL CO., INC. 5160 EXPLORER DRIVE, UNIT 5
MISSISSAUGA L4W-4T7
K101372 BAYLIS MEDICAL CO., INC. 2645 MATHESON BLVD. E
MISSISSAUGA, ONTARIO L4W 5S4
K092337 BAYLIS MEDICAL CO., INC. 2645 MATHESON BLVD. E
MISSISSAUGA, ONTARIO L4W 5S4
K062937 BAYLIS MEDICAL CO., INC. 2580 MATHESON BLVD. E
MISSISSAUGA, ONTARIO L4W 4J1
K121773 BIOMERICS 2700 S 900 W
SALT LAKE CITY UT 84119
K190259 Biomerics 6030 West Harold Gatty Drive
Salt Lake City UT 84116
K183177 Boston Scientific Corporation 25155 Rye Canyon Loop
Valencia CA 91355
K060799 COSMAN MEDICAL, INC. 76 CAMBRIDGE ST.
BURLINGTON MA 01803
K082012 COSMAN MEDICAL, INC. 76 CAMBRIDGE ST.
BURLINGTON MA 01803-4140
K050084 COSMAN MEDICAL, INC. 76 CAMBRIDGE ST.
BURLINGTON MA 01803-4140
K053415 COSMAN MEDICAL, INC. 76 CAMBRIDGE ST.
BURLINGTON MA 01803-4140
K170708 Diros Technology Inc. 120 Gibson Drive
Markham L3R 2Z3
K150371 DIROS TECHNOLOGY, INC. 120 GIBSON DRIVE
MARKHAM L3R 2Z3
K141586 DIROS TECHNOLOGY, INC. 120 GIBSON DRIVE
MARKHAM,ON L3R 2Z3
K102566 DIROS TECHNOLOGY, INC. 232 HOOD ROAD
MARKHAM, ONTARIO L3R 3K8
K110593 DIROS TECHNOLOGY, INC. 232 HOOD ROAD
MARKHAM, ONTARIO L3R 3K8
K041021 EPIMED INTERNATIONAL, INC. 141 SAL LANDRIO DR.
JOHNSTOWN NY 12095
K190256 Epimed International, Inc. 13958 Diplomat Drive
Farmers Branch TX 75234
K011387 EUROLINK LLC. 77 LOCKSLEY RD.
LYNNFIELD MA 01940
K163236 Halyard Health, Inc. 5405 Windward Parkway
Alpharetta GA 30004
K163461 Halyard Health, Inc. 5405 Windward Parkway
Alpharetta GA 30004
K152642 LCCS PRODUCTS LIMITED FLAT A, 9/F ., HENNESSY PLAZA, 164-166 HENNESSY ROAD,
HONG KONG
K112231 LCCS PRODUCTS LIMITED 05C FUJAI KANGLE BUILDING
SHENZHEN, GUANGDONG 518000
K191293 LCCS Products Limited Office 3a-7, 12/F, Kaiser Center, No.18 Center Street, Sai
Hong Kong
K000073 MERCURY MEDICAL 160 SOUTH MAIN ST.
MIDDLETON MA 01949
K090608 MINTA MEDICAL LIMITED CADDICK ROAD
KNOWSLEY MERSEYSIDE L34 9HP
K032196 NEW BUSINESS DEVELOPMENT, LLC 605 INDUSTRIAL COURT
WOODSTOCK GA 30189
K060397 PAJUNK GMBH MEDIZINTECHNOLOGIE KARL-HALL-STRASSE 1
GEISINGEN, BADEN-WURTTEMBERG 78187
K021942 RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP 22 TERRY AVE.
BURLINGTON MA 01803
K980430 RADIONICS, INC. 22 TERRY AVE.
BURLINGTON MA 01803-2516
K991399 RADIONICS, INC. 22 TERRY AVE.
BURLINGTON MA 01803-2516
K153272 RELIEVANT MEDSYSTEMS 2688 MIDDLEFIELD ROAD, SUITE A
REDWOOD CITY CA 94063
K170827 Relievant Medsystems 2688 Middlefield Road, Suite A
Redwood City CA 94063
K180369 Relievant Medsystems 385 Moffett Park Drive, Suite 105
Sunnyvale CA 94089
K190504 Relievant Medsystems 358 Moffett Park Drive, Suite 105
Sunnyvale CA 94089
K213836 Relievant Medsystems, Inc. 1230 Midas Way, Suite 200
Sunnyvale CA 94085
K222281 Relievant Medsystems, Inc. 1230 Midas Way, Suite 200
Sunnyvale CA 94085
K994344 ROCKET MEDICAL PLC FACTORIES 3 & 4,
WASHINGTON, TYNE & WEAR NE37 1NE
K241367 Shanghai SAMedical & Plastic Instruments Co., Ltd. Level 1-4 & Room 501,506,510, Building No.12, No.2755
Shanghai 201100
K071300 SMITH & NEPHEW, INC. 150 MINUTEMAN RD.
ANDOVER MA 01810
K063467 SMITH & NEPHEW, INC. 150 MINUTEMAN RD.
ANDOVER MA 01810
K090955 SMITH & NEPHEW, INC. 1450 BROOKS RD.
MEMPHIS TN 38116
K034012 SMITH & NEPHEW, INC. 150 MINUTEMAN RD.
ANDOVER MA 01810
K250213 Stryker Instruments 1941 Stryker Way
Portage MI 49002
K043442 STRYKER INSTRUMENTS 4100 EAST MILHAM AVE.
KALAMAZOO MI 49001
K032406 STRYKER INSTRUMENTS 4100 EAST MILHAM AVE.
KALAMAZOO MI 49001
K123178 STRYKER INSTRUMENTS, INSTRUMENTS DIV. 4100 EAST MILHAM AVE.
KALAMAZOO MI 49001
K042375 TECHNOMED EUROPE AMERIKALAAN 71
MAASTRICHT AIRPORT 6199 AE
K080771 TOP CORP. 5536 TROWBRIDGE DR
DUNWOODY GA 30338
K062946 TOP CORP. 5536 TROWBRIDGE DRIVE
DUNWOODY GA 30338




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