CORE

  • Model / Serial
    All units manufactured June 23, 2005 through July 22, 2005.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Virginia, Australia, Canada, England, France, Germany, Japan, Netherlands, Sweden, Switzerland,
  • Product Description
    Stryker brand Consolidated Operating Room Equipment (CORE) SystemPowered Instrument Driver, REF 5400-50; Model 5400-050-000A.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Stryker Instruments Div. of Stryker Corporation, 4100 E. Milham, Kalamazoo MI 49001
  • Source
    USFDA

605 devices with a similar name

Learn more about the data here

  • Model / Serial
    Catalog Numbers: Part # BCORE.60, BCORE.80, and BCORE.105
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution in states of: MA, CA, WA, NJ, TX, IL, and FL.
  • Product Description
    Bio-CORE Cannula (Needle) Set
  • Manufacturer
  • Model / Serial
    Lot Number: REYK1575, REYL0126, REYI1423, REYI2144, REYI2147, REYI2257, REYI2259, REYJ0186, REYJ0652, REYJ1221, REYJ2078, REYK0399, REYK0794, REYK1112, REYK1573, REYL0042, REYL0523, REYL1225.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Denmark, Spain, Finland, France, Ireland, Israel, Italy, Netherlands, Poland, Japan and Pakistan.
  • Product Description
    Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm), Product Code: 121416; Monopty Biopsy, Product Code: 000441; Monopty 14g x 10cm (22mm), Product Code: 121410; Monopty 14g x 10cm (11mm), Product Code: 211410. || The BARD MONOPTY Disposable Core Biopsy Instrument is a single use core biopsy device. It is available in several needle gauge sizes and lengths. The actuator button and arrow in the ready window are color coded according to the various gauge sizes, e.g., Yellow=20 gauge, Pink=18 gauge, Purple=16 gauge, Green=14 gauge, and Light Blue=12 gauge. (Only the 14 gauge size has been reported to be affected by this issue). The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
  • Manufacturer
  • Model / Serial
    Head Holder M/N 4535 671 11331. Ingenuity Core - M/N 728321, Serial #s: 7725, 10614, 10663, 50171, 95735, 300072, 310001, 310006, 310008, 310009, 310010, 310012, 310013, 310014, 310015, 310017, 310018, 310020, 310021, 310022, 310024, 310025, 310026, 310028, 310029, 310030, 310031, 310032, 310033, 310034, 310035, 310037, 310038, 310039, 310040, 310041, 310042, 310043, 310044, 310045, 310046, 310047, 310048, 310049, 310050, 310051, 310052, 310053, 310054, 310055, 310056, 310057, 310058, 310059, 310060, 310061, 310062, 310063, 310064, 310065, 310066, 310067, 310068, 310069, 310070, 310071, 310072, 310073, 310074, 310075, 310076, 310077, 310078, 310079, 310080, 3100016, EP16E110078, EP16E120020 & EP16ER110018.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-Product was shipped to the following states: AR, AR, AZ, CA, CO, CT, FL, GA, IA, IN, KS, LA, MA, MD, MI, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA, WV & WY, and to the following countries: Argentina, Australia, Bangladesh, Belgium, Brazil, Bulgaria, China, Colombia, Denmark, Ecuador, France, Germany, India, Indonesia, Israel, Japan, Latvia, Libya, Myanmar, Norway, Oman, Poland, Republic of Korea, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom & Viet Nam.
  • Product Description
    Head Holder shipped with Ingenuity Core Computed Tomography X-ray Systems. || Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
  • Manufacturer
  • Model / Serial
    Model #: 728321; Serial #s: 52000, 52001, 52002, 52004, 52006, 52007, 52008, 52009, 52010, 52013, 52015, 52016, 52017, 52018, 52020, 52021, 52022, 52024, 52026, 52033, 52038, 52039, 52046, 52051, 52052, 52057, 310001, 310002, 310003, 310004, 310005, 310006, 310007, 310009, 310010, 310011, 310012, 310013, 310014, 310015, 310016, 310017, 310018, 310019, 310020, 310021, 310022, 310024, 310025, 310026, 310027, 310028, 310029, 310030, 310031, 310032, 310033, 310034, 310035, 310036, 310037, 310038, 310040, 310041, 310043, 310044, 310045, 310046, 310047, 310048, 310049, 310050, 310051, 310052, 310053, 310054, 310055, 310056, 310057, 310059, 310060, 310061, 310062, 310063, 310064, 310065, 310066, 310068, 310069, 310070, 310071, 310072, 310073, 310074, 310075, 310076, 310077, 310078, 310079, 310080, 310081, 310082, 310083, 310084, 310085, 310086, 310087, 310088, 310089, 310090, 310091, 310092, 310093, 310094, 310095, 310096, 310097, 310099, 310100, 310101, 310102, 310103, 310104, 310105, 310106, 310107, 310108, 310109, 310110, 310111, 310112, 310113, 310114, 310115, 310116, 310117, 310118, 310119, 310120, 310121, 310123, 310124, 310125, 310126, 310128, 310129, 310131, 310132, 310133, 310134, 310135, 310136, 310137, 310138, 310139, 310140, 310141, 310143, 310144, 310145, 310148, 310149, 310151, 310152, 310153, 310154, 310155, 310157, 310158, 310160, 310161, 310162, 310163, 310164, 310165, 310170, 310171, 333001, 333002, 333003, 333005, 333006, 333007, 333008, 333009, 333010, 333011, 333012, 333013, 333014, 333015, 333016, 333017, 333022, 333024, 333025, 333026, 333027, 333030, 333031, 333035, 333037, 333038, 333042, 333044, 333045, 333046, 333051, 333052, 333053, 333055, 333057, 333060, 333061, 333066.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.
  • Product Description
    Ingenuity Core (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
  • Manufacturer
  • Model / Serial
    Model #: 728323; Serial #s: 30153, 32002, 32003, 32004, 32005, 32006, 32007, 32009, 32010, 32011, 32013, 32014, 32015, 32016, 32018, 32021, 32023, 32025, 32026, 32029, 32030, 32031, 32032, 32033, 32034, 32035, 32036, 32037, 32038, 32040, 32041, 32042, 32043, 32044, 32046, 32047, 32048, 32049, 32051, 32052, 32053, 32054, 32057, 32059, 32060, 32062, 32064, 32066, 32068, 32069, 32070, 32072, 32073, 32074, 32077, 32078, 32080, 32083, 32084, 32089, 32091, 32092, 32094, 32095, 32098, 32100, 32101, 32104, 32106, 32107, 32108, 300137, 310067, 320001, 320002, 320003, 320004, 320005, 320006, 320007, 320008, 320009, 320010, 320011, 320013, 320014, 320015, 320018, 320019, 320020, 320021, 320022, 320023, 320024, 320025, 320026, 320027, 320028, 320029, 320030, 320031, 320032, 320033, 320034, 320035, 320036, 320037, 320038, 320039, 320040, 320041, 320043, 320044, 320045, 320046, 320047, 320048, 320049, 320050, 320051, 320052, 320053, 320054, 320055, 320056, 320057, 320059, 320060, 320062, 320063, 320064, 320065, 320066, 320067, 320068, 320069, 320070, 320071, 320072, 320073, 320074, 320075, 320076, 320077, 320078, 320079, 320080, 320081, 320082, 320083, 320084, 320085, 320086, 320087, 320088, 320089, 320090, 320092, 320093, 320095, 320096, 320097, 320098, 320099, 320101, 320102, 320103, 320104, 320105, 320106, 320107, 320109, 320110, 320111, 320112, 320114, 320115, 320116, 320117, 320118, 320119, 320120, 320121, 320122, 320123, 320124, 320125, 320126, 320128, 320129, 320131, 320132, 320133, 320134, 320135, 320137, 320138, 320139, 320140, 320141, 320142, 320143, 320144, 320145, 320146, 320147, 320148, 320150, 336001, 336002, 336003, 336006, 336007, 336008, 336009, 336010, 336011, 336012, 336013, 336014, 336015, 336016, 336018, 336020, 336021, 336024, 336027, 336028, 336029, 336030, 336031, 336032, 336033, 336034, 336035, 336036, 336037, 336038, 336039, 336040, 336042, 336043, 336044, 336046, 336047, 336048, 336050, 336052, 336055, 336056, 336057, 336058, 336059, 336061, 336063, 336066, 336067, 336068, 336069, 336070, 336071, 336072, 336074, 336075, 336076, 336080, 336081, 336086, 336087, 336089, 336702, 336703, 336704, 336705, 336706, 336708, 336709, 336710, 336711, 336713, 336714, 336715, 336716, 336717, 336718, 336719, 336721, 336707
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.
  • Product Description
    Ingenuity Core 128 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
  • Manufacturer
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