Medtronic Cardiovascular Revascularization & Surgical Therap

7 dispositivos en la base de datos

  • Modelo / Serial
    Lot 10279571, Use By 2012-01-31
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distribution to one medical facility in MN.
  • Descripción del producto
    Medtronic, Transfer Spike, Blood Processing Accessory, REF BT945, Sequestration Kits
  • Modelo / Serial
    Lot Numbers: 0000570588, 0000574333, 0000597907, 0000597954, 0000603799, 0000603854, 0000604000, 0000604584, 0000604619, 0000607627, 0000611283, 0000617833, 0000624995, 0000628687, 0000641735, 0000644599, 0000645307, 0000648997, 0000653336, 0000654111, 000065606, 0000662898, 0000666630, 0000666650, 0000676750, 0000680771, 0000682337, 0000697089, 0000699592, 0000708267, 0000708363, 0000712299, 0000721526, 0000727448, 0000738389, 0000756494, 0000762708, 0000797022, 0000805167, 0000805376, 0000806225, 0000806808, 0000812913, 0000838110, 0000846202, 0000849687, 0000850497, 0000854152, 0000854999, 0000856172 and 0000969188.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US including states of AZ, CA, CO, CT, DE, FL, HI, IL, IN, LA, MI, MN, NC, NJ, NM, NV, NY,OH, OK, PA, TN, TX, and WI and countries of Australia, Japan and Venezuela.
  • Descripción del producto
    Medtronic Ideal MAXPAC Total System, Catalog Numbers: TS1262R6, TS1262R7, TS1420R, TS1420R1, TS1442R, TS1446R, TS1464T, TS1470R, TS1470T1, TS1480R3, TS1480R5, TS1480R6, TS1487R, TS1487R2, TS8040R28, TS8108R6, TS8163R10, TS8387R5, TS9412R3, TS9453R28, TS9764R9, TS9800R28, TS9800R29, TS9800R31, TS9987R33 and TS9987R34. || Sterile and nonpyrogenic, EtO or Gamma Sterilized. Medtronic Purfusion Systems. || Kits are packaging convenience kits containing previously released sterile-pack products and accessories.
  • Modelo / Serial
    Lot Numbers: 0000567714, 0000569193, 0000569453, 0000571627, 0000574238, 0000579154, 0000579157 and 0000580322.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US including states of AZ, CA, CO, CT, DE, FL, HI, IL, IN, LA, MI, MN, NC, NJ, NM, NV, NY,OH, OK, PA, TN, TX, and WI and countries of Australia, Japan and Venezuela.
  • Descripción del producto
    Medtronic One Source Pack Magellan, Catalog Number: COS310. || Kits are packaging convenience kits containing previously released sterile-pack products and accessories. || Medtronic Ideal MAXPAC Total System
  • Modelo / Serial
    Lot Numbers: 0000574290, 0000574314, 0000574316, 0000580205, 0000608559, 0000618615, 0000640122, 0000640634, 0000771456, 0000772227, 0000777567, 0000780964, 0000781651, 0000800394, 0000920163, 0000739503 and 0000950662.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US including states of AZ, CA, CO, CT, DE, FL, HI, IL, IN, LA, MI, MN, NC, NJ, NM, NV, NY,OH, OK, PA, TN, TX, and WI and countries of Australia, Japan and Venezuela.
  • Descripción del producto
    Medtronic One Source Pack, Catalog Numbers: ATLS21, ATLS24, ATLS2469, EC1S24, EC2S00, EC2S24, EE1S048 and EE2S21. || Kits are packaging convenience kits containing previously released sterile-pack products and accessories.
  • Modelo / Serial
    Lot numbers: 0509537, 0509640, 509755, 0510102, 0511801, 0512206, 0512406, 0512528, 0516564, 0516805, 0517446, 0517447, 0518048, 0518149, 0518643, 0518701, 0519441, 0519442, 0519552, 0519553, 0520004, 0520005, 0520218, 0520219, 0520929, 0520930, 0523108, 0523109, 0523529, 0523629, 0525614, 0525615, 0525722, 0526317, 0526330, 0526518, 0526519, 0527001, 0529801, 0529802, 0529914, 0530028, 0530029, 0530101, 0530102, 0530103, 0530104, 0530105, 0530602, 0530707, 0530802, 0532125, 0532126, 0532127, 0532128, 0532630, 0532719, 0532735, 0532829, 0532904, 0532905, 0532907, 0533301, 0533335, 0533401, 0533421, 0533509, 0533537, 0533538, 0534017, 0534123, 0534124, 0534125, 0534126, 0534201, 0600501, 0600502, 0600931, 0600932, 0601119, 0601120, 0601333, 0601334, 0601601, 0601602, 0601703, 0602303, 0602304, 0603017, 0603018, 0603105, 0603205, 0603206, 0603207, 0604414, 0604415, 0605106, 0605107, 0605403, 0606601, 0607201, 0607202, 0607903, 0607904, 0608607, 0614210, 0623313, 0623606, 0623607, 0625412, 0625708, 0626201, 0626202, 0626203, 6036442, 6036670, 6109808, 6109921, 6109955, 6110083, 6138406, 6185510, 6197801, 6197828, 7004186, 7132081, 7146061, 7147793, 7147806, 7352981, 7451269, 7460608, 7479974, 7589735, 7639747, 7661223, 7681451, 7972937, 7979266, 8189696, 8277354, 8289638, 8306418, 8393857, 8521396, 8591790, 8629823, 8646480, 8675184, 8792196, 8898855, 9018451, 9036333, 9145329, 9156757, 9264475, 9323332, 9343587, 9381161, 9498440, 9498589, 9522139, 9569658, 9569711, 9598408, 9602041, 9603836, 9632400, 9685157, 9693616, 9695953, 9695961, 9695988, 9739629, 9739670, 9769262, 9779938, 9790387, 9790395, 9806955, 9806964, 9806969, 9806972, 9806974, 9807053, 9822530, 9855639, 9856396, 9861501, 9866062, 9867454, 9868936, 9872244, 9872246, 9879754, 9879755, 9880630, 9885376, 9886127, 9886150, 9889117, 9889118, 9896073, 9896079, 9898916, 9899409, 9905053, 9914662, 9914664, 9951987, 9953209, 9954653, 9955080, 9962340, 9964925, 9964932, 9964933, 9972391, 9972392, 9975062, 9979217, 9983473, 10002996, 10003686, 10014769, 10017111, 10026931, 10031165, 10032632, 10034838, 10036286, 10036287, 10044003, 10044004, 10044005, 10051493, 10053662, 10053663, 10053664, 10071125, 10071127, 10071130, 10076492, 10076493, 10076494, 10076495, 10087478, 10087479, 10087481, 10097088, 10097089, 10097090, 10103752, 10103753, 10112428, 10112429, 10112431, 10112432, 10120939, 10135522, 10135524, 10135526, 10135529, 10197760, 10197768, 10197776, 10197781, 10282249, 10282251, 10282252, 10282254, 10282255, 10296725, 10296728, 10307473, 10307474, 10315453, 10315454, 10315455, 10315456, 10325134, 10325135, 10335048, 10347695, 10347696, 10347698, 10347700, 10365897, 10365898, 10372654, 10372656, 10375862, 10375863, 10398877, 10398878, 10398879, 10398880, 10407000, 10428853, 10444975, 10446876, 10469219, 10472750, 10472751, 10475205, 10480924, 10480926, 10480927, 10485845, 10485846, 10485847, 10488358, 10495393, 10495394, 10495398, 10497009, 10500586, 10519438, 10527121, 10535508, 10535509, 10537711, 10541287, 10541288, 10561651, 10561652, 10561653, 10561654, 10561656, 10582159, 10582161, 10582163, 10587526, 10590657, 10590658, 10590660, 10590661, 10656233, 10656234, 10656235, 10656236, 10665853, 10665854, 10665855, 10671984, 10671991, 10675076, 10686976, 10686977, 10686978, 10686979, 10691192, 10691195, 10711510, 10806542, 10806546, 10806551.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: USA including states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and countries of Australia, Belgium, Canada, China, France, Germany, Greece, Hong Kong, Hungary, Japan, Korea, Netherlands, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Kingdom, and Venezuela.
  • Descripción del producto
    Medtronic U-CLIP Double Arm Approximation Device, model V100D U-Clip, Catalog Number V100DRFRN2. Sterilized using Irradiation. The U-Clip consists of specially designed vascular clips optionally connected to needles via flexible members. These clips may or may not include coils surrounding a Nitinol wire core. This design allows precise placement of clips prior to closure and facilitation from standard medical and implantable grade materials. Accessories include Clip delivery and removal devices as well as vessel cutting and retention tools. || The Coalescent Surgical U-CLIP is intended for endoscopic and non-endoscopic general soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomoses in blood vessels, grafts and other tubular structures; including use in cardiovascular and coronary artery bypass grafting procedures.
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Más información acerca de la data acá

  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Representante del fabricante
    Gulf Medical Co.
  • Source
    SFDA
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Representante del fabricante
    Gulf Medical Co. Jeddah , (02) 6512828
  • Source
    SFDA