6 results
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25ms
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Sources: EU EUDAMED, US FDA
AB ULAX
FDA registration
AB ULAX·2 products·🇸🇪 Sweden
1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat Moisture Exchangers (HM Es) are designed to enhance humification of ventilator-dependent and non-ventilator dependent patients in critical care, home care and anesthesia.
FDA Enforcement
Class II
·Terminated·AB ULAX·October 14, 2020
1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat Moisture Exchangers (HM Es) are designed to enhance humification of ventilator-dependent and non-ventilator dependent patients in critical care, home care and anesthesia.
FDA Recall
Terminated
·AB ULAX Merkuriusgatan 8 Motala Sweden·Product code BYD·September 4, 2020
AUTO SUTURE ENDO GIA II 60-4.8 SULU
FDA Adverse Event
Injury
·UNITED STATES SURGICAL CORP·Product code GCJ·April 24, 2001
TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Catalog # 5541-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB).
FDA Enforcement
Class II
·Terminated·Howmedica Osteonics Corp.·October 9, 2019
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·February 17, 2017