202 results
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28ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
MONARCH Bronchoscope. Model Number: MBR-000211-B
FDA Enforcement
Class II
·Ongoing·Auris Health, Inc·November 26, 2025
Medline Convenience kits labeled as: PUH ESOPHAGECTOMY CDS, Pack Number CDS984309I
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024
Medline Convenience kits, labeled as: BIOPSY TRAY-LF, Pack Number DYNDH1229
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024
Medline procedural kits labeled as: NEURO TRAY, Pack Number DYNJ55909B
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 4, 2024
Centurion procedure kits labeled as NEURO ANGIO PACK, Pack Number DYNDA1431A
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 14, 2024
Medline procedural kits labeled as: CIRCUMCISION TRAY, Pack Number DYNDA2271
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 4, 2024
Medline procedural kits labeled as: ARTHROGRAPH TRAY, Pack Number MNS12670A
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 4, 2024
Medline Convenience kits labeled as: KIT VASCULAR IVC FILTER PLACEM, Pack Number DYKMBNDL37AH
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024
Medline Convenience kits labeled as: KIT,ER SUTURE #1, Pack Number DYNDS1130A
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024
Medline Convenience kits labeled as: ADMIT KIT PILLOW BOX, Pack Number DYKA1389
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024
Centurion procedure packs, containing Caina syringes, labeled as: SHAVE KIT, Pack Number MNS8250
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 4, 2024
Medline procedure kits labeled as: 1) EYE PACK, Pack Number VAL038BSCLC
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·March 26, 2025
Medline Convenience kits labeled as: MUNCY PACK, Pack Number DYNJ03097D
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024
Medline procedure packs containing Shenli syringes, labeled as follows: NEURO ANGIO PACK, Pack Number DYNDA1431A
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 4, 2024
Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·March 26, 2025
Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 2, 2025
Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 2, 2025
Medline procedure kits labeled as: 1) GENERAL ENDOSCOPY PACK, Pack Number DYNJ44673G
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 2, 2025
Medline procedure kits labeled as: 1) LACERATION TRAY, Pack Number DYNJ17328B
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 2, 2025