5 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01 138903-01 138905-01 138906-01 138907-01 138908-01 138909-01 138910-01 138911-01 138912-01 138913-01 138914-01 138915-01 138916-01 138917-01 138918-01 138919-01 138920-01 138921-01 138922-01 138923-01 138924-01 138926-01 138927-01 138928-01 138929-01 138930-01 138931-01 138932-01 138933-01 138934-01 138936-01 138937-01 138938-01 138939-01 138940-01 138941-01 138942-01 138943-01 138944-01 138945-01 138946-01 138947-01 138948-01 138949-01 138950-01 138951-01 138952-01 138953-01 138954-01 138955-01 138956-01 138957-01 138958-01 138959-01 138960-01 138961-01 138962-01 138963-01 138964-01 138965-01 138966-01 138967-01 138968-01 138969-01 138970-01 138971-01 138972-01 138973-01 138974-01 138975-01 138976-01 138977-01 138978-01 138989-01 138990-01 139000-01 139001-01 139002-01 139011-01 139013-01 139016-01 139018-01 139019-01 139020-01 139021-01 139022-01 139023-01 139028-01 139062-01 139063-01 139073-01 139082-01 139084-01 139085-01 139086-01 139091-01 139122-01 139125-01 139126-01 139127-01 139128-01 139131-01 139141-01 139142-01 139156-01 139163-01 139170-01 139171-01 139172-01 139174-01 139175-01 155081-01 155082-01 155083-01 155084-01 155085-01 155086-01 155087-01 155088-01 155089-01 155090-01 155091-01 155092-01 155093-01 155094-01 155095-01 155096-01 155097-01 155098-01 155099-01 155100-01 155101-01 155102-01 155103-01 155104-01 155105-01 155106-01 155107-01 155108-01 155109-01 155110-01 155111-01 155112-01 155113-01 155114-01 155115-01 155116-01 155117-01 155118-01 155119-01 155120-01 155121-01 155122-01 155123-01 155124-01 155125-01 155126-01 155127-01 155128-01 155129-01 155130-01 155131-01 155132-01 155133-01 155134-01 155135-01 155136-01 155137-01 155138-01 155139-01 155140-01 155141-01 155142-01 155143-01 155144-01 155145-01 155146-01 155147-01 155148-01 155149-01 155150-01 155151-01 155152-01 155153-01 155154-01 155155-01 155156-01 155157-01 155159-01 155160-01 155161-01 155163-01 155165-01 155166-01 155167-01 155168-01 155169-01 155171-01 155288-01 155293-01 155294-01 155299-01 155302-01 155303-01 155304-01 155305-01 155310-01 155311-01 169-03 169-04 169-05 169-06 169-07 169-08 169-09 169-10 169-100 169-101 169-102 169-103 169-104 169-105 169-106 169-107 169-108 169-109 169-11 169-110 169-111 169-112 169-113 169-114 169-115 169-12 169-120 169-124 169-125 169-127 169-128 169-129 169-13 169-131 169-132 169-137 169-138 169-139 169-14 169-140 169-141 169-142 169-143 169-144 169-145 169-15 169-150 169-151 169-152 169-155 169-156 169-159 169-16 169-160 169-161 169-162 169-163 169-164 169-18 169-19 169-20 169-21 169-22 169-23 169-24 169-25 169-26 169-27 169-28 169-29 169-30 169-31 169-32 169-33 169-34 169-35 169-36 169-37 169-38 169-39 169-40 169-41 169-42 169-43 169-44 169-45 169-46 169-47 169-48 169-49 169-50 169-51 169-52 169-53 169-54 169-55 169-56 169-57 169-58 169-59 169-60 169-61 169-62 169-63 169-64 169-65 169-66 169-67 169-68 169-69 169-70 169-71 169-72 169-73 169-74 169-75 169-76 169-77 169-78 169-79 169-80 169-81 169-82 169-83 169-84 169-85 169-86 169-87 169-88 169-89 169-90 169-91 169-92 169-93 169-94 169-95 169-96 169-97 169-98 169-99
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·November 5, 2025
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare, Llc·February 5, 2014
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024