FDA 510(k) Applications for Medical Device:
Catheter, Recording, Electrode, Reprocessed

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K012708 ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST.
PHOENIX AZ 85044
K030109 ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST.
PHOENIX AZ 85044
K052603 ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST.
PHOENIX AZ 85044
K030026 ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST.
PHOENIX AZ 85044
K030279 ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST.
PHOENIX AZ 85044
K052414 ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST.
PHOENIX AZ 85044
K043392 ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST.
PHOENIX AZ 85044
K061045 ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST.
PHOENIX AZ 85044
K043393 ALLIANCE MEDICAL CORP. 10232 SOUTH 51ST ST.
PHOENIX AZ 85044
K030187 ALLIANCE MEDICAL, INC. 10232 SOUTH 51 ST.
PHOENIX AZ 85044
K100254 ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST.
PHOENIX AZ 85044
K081329 ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST.
PHOENIX AZ 85044
K082023 ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST.
PHOENIX AZ 85044
K090323 ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST.
PHOENIX AZ 85044
K161464 Innovative Health, LLC 1435 North Hayden Road, Suite 100
Scottsdale AZ 85257
K153153 INNOVATIVE HEALTH, LLC 1435 NORTH HAYDEN ROAD, SUITE 100
SCOTTSDALE AZ 85257
K160242 INNOVATIVE HEALTH, LLC 1435 NORTH HAYDEN ROAD, SUITE 100
SCOTTSDALE AZ 85257
K193263 Innovative Health, LLC. 1435 North Hayden Road, Suite 100
Scottsdale AZ 85257
K181458 Innovative Health, LLC. 1435 North Hayden Road, Suite 100
Scottsdale AZ 85257
K171503 Innovative Health, LLC. 1435 North Hayden Road
Scottsdale AZ 85257
K180710 Innovative Health, LLC. 1435 North Hayden Road
Scottsdale AZ 85257
K211276 Innovative Health, LLC. 1435 North Hayden Road, Suite 100
Scottsdale AZ 85257
K171788 Innovative Health, LLC. 1435 North Hayden Road, Suite 100
Scottsdale AZ 85257
K160421 Innovative Health, LLC. 1435 North Hayden Road, Suite 100
Scottsdale AZ 85257
K160496 Innovative Health, LLC. 1435 North Hayden Road, Suite 100
Scottsdale AZ 85257
K190127 Innovative Health, LLC. 1435 North Hayden Road, Suite 100
Scottsdale AZ 85257
K181897 Innovative Health, LLC. 1435 North Hayden Road, Suite 100
Scottsdale AZ 85257
K161393 Innovative Health, LLC. 1435 North Hayden Road, Suite 100
Scottsdale AZ 85257
K160303 Innovative Health, LLC. 1435 North Hayden Road, Suite 100
Scottsdale AZ 85257
K191170 Innovative Health, LLC. 1435 North Hayden Road, Suite 100
Scottsdale AZ 85257
K182488 Innovative Health, LLC. 1435 North Hayden Road, Suite 100
Scottsdale AZ 85257
K161827 INNOVATIVE HEALTH, LLC. 1435 NORTH HAYDEN ROAD
SCOTTSDALE AZ 85257
K181618 Innovative Health, LLC. 1435 North Hayden Road, Suite 100
Scottsdale AZ 85257
K162251 Innovative Health, LLC. 1435 North Hayden Road
Scottsdale AZ 85257
K170922 Innovative Health, LLC. 1435 North Hayden Road, Suite 100
Scottsdale AZ 85257
K203655 Innovative Health, LLC. 1435 North Hayden Road, Suite 100
Scottsdale AZ 85257
K221854 Innovative Health, LLC. 1435 North Hayden Road
Scottsdale AZ 85257
K051220 STERILMED, INC. 11400 73RD AVE. NORTH
MAPLE GROVE MN 55369
K101789 STERILMED, INC. 11400 73RD AVE. N.
MAPLE GROVE MN 55369
K012523 STERILMED, INC. 11400 73RD AVE. NORTH
MAPLE GROVE MN 55369
K092158 STERILMED, INC. 11400 73RD AVE. NORTH
MAPLE GROVE MN 55369
K121158 STERILMED, INC. 11400 73RD AVE. NORTH
MAPLE GROVE MN 55369
K150357 STERILMED, INC. 5010 Cheshire Pkwy Ste 2
Plymouth MN 55446
K153006 STERILMED, INC. 5010 Cheshire Parkway N, Suite 2
Plymouth MN 55446
K012678 STERILMED, INC. 11400 73RD AVE. NORTH
MAPLE GROVE MN 55369
K043513 STERILMED, INC. 1140O 73RD AVE. NORTH
MINNEAPOLIS MN 55369
K112292 STRYKER SUSTAINABILITY SOLUTIONS 1810 W. Drake Dr.
Tempe AZ 85283
K200205 Stryker Sustainability Solutions 1810 W Drake Drive
Tempe AZ 85283
K181056 Stryker Sustainability Solutions 1810 W. Drake Drive
Tempe AZ 85283
K112232 STRYKER SUSTAINABILITY SOLUTIONS 1810 W. Drake Dr.
Tempe AZ 85283
K161272 Surgical Instrument Service and Savings Inc (dba Medline ReNewal)
Redmond OR 97756
K151617 SURGICAL INSTRUMENT SERVICE AND SAVINGS INC (DBA MEDLINE REN 2747 SW 6TH ST.
REDMOND OR 97756
K221067 Surgical Instrument Service and Savings Inc. (dba Medline ReNewal)
Redmond OR 97756
K012687 VANGUARD MEDICAL CONCEPTS, INC. 5307 GREAT OAK DR.
LAKELAND FL 33815
K012688 VANGUARD MEDICAL CONCEPTS, INC. 5307 GREAT OAK DR.
LAKELAND FL 33815
K022316 VANGUARD MEDICAL CONCEPTS, INC. 5307 GREAT OAK DR.
LAKELAND FL 33815
K023180 VANGUARD MEDICAL CONCEPTS, INC. 5307 GREAT OAK DR.
LAKELAND FL 33815
K030114 VANGUARD MEDICAL CONCEPTS, INC. 5307 GREAT OAK DR.
LAKELAND FL 33815
K040751 VANGUARD MEDICAL CONCEPTS, INC. 5307 GREAT OAK DR.
LAKELAND FL 33815
K042074 VANGUARD MEDICAL CONCEPTS, INC. 5307 GREAT OAK DR.
LAKELAND FL 33815
K050763 VANGUARD MEDICAL CONCEPTS, INC. 5307 GREAT OAK DR.
LAKELAND FL 33815
K051043 VANGUARD MEDICAL CONCEPTS, INC. 5307 GREAT OAK DR.
LAKELAND FL 33815




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