7 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: MAF-DM2, MAF-GM, MAF-GM2, MAF-TM, MAF-TM2.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Olympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·September 6, 2023
Olympus Airway Mobilescope, Models MAF-GM & MAF-TM.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·September 6, 2023
Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW
FDA Enforcement
Class II
·Ongoing·SPINEART SA·August 20, 2025
Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW Component: No
FDA Enforcement
Class II
·Ongoing·SPINEART SA·August 20, 2025
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUDKINS PACK DYNJ51126 ANGIO PACK DYNJ32555C, DYNJ66631 ANGIO TRAY DYNJ46153B ANGIOGRAPHY PACK DYNJ26855F ANGIOGRAPHY PACK-M-LF DYNJ24530I ANGIOGRAPHY TRAY-LF DYNJ0220880V, DYNJ30077D CATH LAB ANGIO PACK-LF DYNJ0545064X CATH LAB PACK DYNJ39057C FEMORAL ANGIOGRAPY SET UP DYNJ61015B RAD-ANGIO PACK DYNJ47710C SURGERY ANGIO PACK-LF PHS677784013A
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·April 29, 2026
MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK MINI MAIN, REF: 1147-00 BD PYXIS MEDBANK Facility Software, REF: 139090-01; BD PYXS MEDBNK TWR MN 2HH1FH2HM2FM2FG1FF, REF: 169-100; BD PYXIS MEDBANK MINI 1HH-1FH- 1HM, REF: 169-101; BD PYXIS MEDBANK MINI 1HH-1HM- 1FM, REF: 169-102; BD PYXIS MEDBANK MINI 1HH-3HM, REF: 169-103; BD PYXIS MEDBANK MINI 2FH, REF: 169-104; BD PYXIS MEDBANK MINI 2FM, REF: 169-105; BD PYXIS MEDBANK MINI 2HH-1FH, REF: 169-106; BD PYXIS MEDBANK MINI 2HH-1FM , REF: 169-107; BD PYXIS MEDBANK MINI 2HH-2HM, REF: 169-108; BD PYXIS MEDBANK MINI 2HM-1FM, REF: 169-109; BD PYXIS MEDBANK MINI 3HH-1FG, REF: 169-110; BD PYXIS MEDBANK MINI 3HH-1HM, REF: 169-111; BD PYXIS MEDBANK MINI 4HH, REF: 169-112; BD PYXIS MEDBANK MINI 4HM, REF: 169-113; BD PYXIS MDBANK TWR MN 7HH-1HM-3FM RxNow, REF: 169-132; BD PYXIS MEDBANK MINI 1FH-1FM, REF: 169-137; BD PYXIS MEDBANK TWR MN 1FH- 10HM-1FM, REF: 169-138; BD PYXIS MEDBANK TWR MN 2HH- 4FH-2FM, REF: 169-139; OBS BD PYXIS MB TOWER MAIN, REF: 169-153; OBS BD PYXIS MB TWR RXNOW MAIN W/MED PRI, REF: 169-155; OBS BD PYXIS MB TWR RXNOW MAIN W/PAT PRI, REF: 169-156; OBS BD PYXIS MB MINI MAIN W/CUBIE DRWS, REF: 169-159; OBS BD PYXIS MB MINI MAIN W/MATRIX DRWS, REF: 169-160; OBS BD PYXIS MB MINI MAIN W/HH FALSE DRW, REF: 169-161; OBS BD PYXIS MB MINI MAIN W/FH FALSE DRW, REF: 169-162; BD PYXIS MEDBANK TWR MN 10HH- 1FH-1FM, REF: 169-23; BD PYXIS MEDBANK TWR MN 10HH- 2FH, REF: 169-24; BD PYXIS MEDBANK TWR MN 10HH- 2FM, REF: 169-25; BD PYXIS MEDBANK TWR MN 12HH- 1FF, REF: 169-26; BD PYXIS MEDBANK TWR MN 12HH- 1FH, REF: 169-27; BD PYXIS MEDBANK TWR MN 12HH- 1FM, REF: 169-28; BD PYXIS MEDBANK TWR MN 14HH, REF: 169-29; BD PYXIS MEDBANK TWR MN 1HH- 1HM-2FM-4FF, REF: 169-30; BD PYXIS MEDBANK TWR MN 2FH- 2HM-4FM, REF: 169-31; BD PYXIS MEDBANK TWR MN 2HH- 10HM-1FM, REF: 169-32; BD PYXIS MEDBANK TWR MN 2HH- 1FH-5FM, REF: 169-33; BD PYXIS MEDBANK TWR MN 2HH- 2FH-4FM, REF: 169-34; BD PYXIS MEDBANK TWR MN 2HH- 2FM-4FF, REF: 169-35; BD PYXIS MEDBANK TWR MN 2HH- 4HM-4FF, REF: 169-36; BD PYXIS MEDBANK TWR MN 2HH- 4HM-4FM, REF: 169-37; BD PYXIS MEDBANK TWR MN 2HH- 6FM, REF: 169-38; BD PYXIS MEDBANK TWR MN 2HH- 6HM-3FM, REF: 169-39; BD PYXIS MEDBANK TWR MN 2HH- 8HM-2FM, REF: 169-40; BD PYXIS MEDBANK TWR MN 2HM- 6FM, REF: 169-41; BD PYXIS MEDBANK TWR MN 3FH-4FM , REF: 169-42; BD PYXIS MEDBANK TWR MN 3HH- 7HM-2FM, REF: 169-43; BD PYXIS MEDBANK TWR MN 4HH- 10HM, REF: 169-44; BD PYXIS MEDBANK TWR MN 4HH- 1FH-2HM-3FM, REF: 169-45; BD PYXIS MEDBANK TWR MN 4HH- 1FH-4FM, REF: 169-46; BD PYXIS MEDBANK TWR MN 4HH- 1FH-4HM-2FM, REF: 169-47; BD PYXIS MEDBANK TWR MN 4HH- 1FH-6HM-1FM, REF: 169-48; BD PYXIS MEDBANK TWR MN 4HH- 2FH-2HM-2FM, REF: 169-49; BD PYXIS MEDBANK TWR MN 4HH- 2FH-3FM, REF: 169-50; BD PYXIS MEDBANK TWR MN 4HH- 2HM-4FM, REF: 169-51; BD PYXIS MEDBANK TWR MN 4HH- 3FH-2FM, REF: 169-52; BD PYXIS MEDBANK TWR MN 4HH- 4FH-1FM, REF: 169-53; BD PYXIS MEDBANK TWR MN 4HH- 4HM-3FM, REF: 169-54; BD PYXIS MEDBANK TWR MN 4HH-5FH, REF: 169-55; BD PYXIS MEDBANK TWR MN 4HH- 5FM, REF: 169-56; BD PYXIS MEDBANK TWR MN 4HH- 6HM-2FM, REF: 169-57; BD PYXIS MEDBANK TWR MN 4HH- 8HM-1FM, REF: 169-58; BD PYXIS MEDBANK TWR MN 4HM- 5FM, REF: 169-59; BD PYXIS MEDBANK TWR MN 5HH- 3HM-3FM, REF: 169-60; BD PYXIS MEDBANK TWR MN 5HH- 9HM, REF: 169-61; BD PYXIS MEDBANK TWR MN 6FH-1FM, REF: 169-62; BD PYXIS MEDBANK TWR MN 6HH- 1FH-2HM-2FM, REF: 169-63; BD PYXIS MEDBANK TWR MN 6HH- 1FH-3FM, REF: 169-64; BD PYXIS MEDBANK TWR MN 6HH- 2FH-2FM, REF: 169-65; BD PYXIS MEDBANK TWR MN 6HH- 2FH-2HM-1FM, REF: 169-66; BD PYXIS MEDBANK TWR MN 6HH-4FH, REF: 169-67; BD PYXIS MEDBANK TWR MN 6HH- 4FM, REF: 169-68; BD PYXIS MEDBANK TWR MN 6HH- 4HM-2FM, REF: 169-69; BD PYXIS MEDBANK TWR MN 6HH- 6HM-1FM, REF: 169-70; BD PYXIS MEDBANK TWR MN 6HH- 8HM, REF: 169-71; BD PYXIS MEDBANK TWR MN 7FH, REF: 169-72; BD PYXIS M
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·April 23, 2025