Integra LifeSciences Corporation

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 7 건

  • 모델명 / 제조번호(시리얼번호)
    All Lot numbers of Mayfield Ultra 360 Base Units, Catalogue #'s A2009 and A2029.   Affected Lot Numbers For Catalogue No. A2009  73149, 73355, 73356, 74396, 74730, 74398, 74399, 75796, 75816, 74523, 75838, 75859, 74524, 75873, 74890, 75939, 74892, 76420, 74893, 74894, 74895, 76156, 77225, 76157, 76158, 77831, 76159, 77957, 76160, 78012, 76161, 78548, 77292, 78666, 79067, 79068, 79069, 79071, 80013, 79073, 81782, 79074, 81918, 79075, 79748, 80094, 82194, 80095, 80668, 80669, 84171, 80671, 84288, 82736, 82737, 82738, 85896, 82739, 86400, 82740, 82741, 82742, 84732, 84733, 84734, 84735, 85693, 86817, 86818, 86819, 86820, 86821, 86822, 89453, 89455, 89456, 89457, 92296, 92297, 92298, 92299, 92300, 92301, 94653, 94654, 94655, 99798, 98558, 98559, 98560, 98561, 98562, 94658, 103127, 103128, 103129, 103130, 103131, 104890, 114978, 115809, E19251, 123051  Affected Lot Numbers For Catalogue No. A2029 84180, 84487, 85519, 85815, 85631, 84887, 84888, 86533, 86534, 84889, 86828, 86829, 89302, 86830, 86831, 86832, 86833, 86834, 89534, 89535, 89536, 89537, 89538, and 94167.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY, and DC. (25 government consignees) and in the foreign countries: CANADA, ALGERIA, ARAB EMIRATES, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CHILE, CHINA, COLUMBIA, CYPRESS, DENMARK, DOMINICAN REPUBLIC, FRANCE, GERMANY, GREAT BRITAN, HONG KONG, HUNGARY, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN , JORDAN, KOREA, LIBYA, MACEDONIA, MAYLASIA, MEXICO, NETHERLANDS, POLAND, PORTUGAL, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI LANKA, TAIWAN, THAILAND, and TURKEY.
  • 제품 설명
    The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package. || Product Usage: || This product provides the ability to position and hold a patient head while the patient is in the prone, supine, lateral or park-bench and sitting positions. It is intended to be used during diagnostic examinations or surgical procedures where a rigid support between the surgical table and a headrest or skull clamp is necessary and positional freedom is required.
  • 모델명 / 제조번호(시리얼번호)
    The recalle product is identified with the Lot Numbers: 097547 and 096546.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OK, OR, PA TN, TX, UT, VA, WA and WI.
  • 제품 설명
    MAYFIELD Composite Series Base Unit, Model A3101, a Swivel Adaptor (A3018) is an integral component of the Base Unit, Model A3101. || The MAYFIELD Base Unit (A3101) is an operating room table accessory intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used. A Swivel Adaptor (A3018) is an integral component of the Base Unit A3101.
  • 모델명 / 제조번호(시리얼번호)
    The recalled product is identified with the Lot Numbers: 096455 and 097546.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OK, OR, PA TN, TX, UT, VA, WA and WI.
  • 제품 설명
    MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. || The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.
  • 모델명 / 제조번호(시리얼번호)
    Part Number: 111432SND  Lot Number: E6CZ
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide distribution - Alabama, Arizona, Colorado, Connecticut, Maryland, Michigan, New England, New Jersey, North Carolina, Ohio, South Carolina, Nebraska, and Utah.
  • 제품 설명
    Qwix 4.3mm Stabilization Screws - 32mm
  • 모델명 / 제조번호(시리얼번호)
    Part Number: 111434SND  Lot Number: E6DO
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide distribution - Alabama, Arizona, Colorado, Connecticut, Maryland, Michigan, New England, New Jersey, North Carolina, Ohio, South Carolina, Nebraska, and Utah.
  • 제품 설명
    Qwix 4.3mm Stabilization Screws - 34mm
하나 더 2 건 더