13 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INHANCETM Reverse Glenoid Peripheral Posts
FDA 510(k)
FDA Class 2
·Orthopedic
EUROTROL HEMATOCRIT CONTROL
FDA 510(k)
FDA Class 2
·Hematology
AUTOCON II 400 ELECTROSURGICAL GENERATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
METRX SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code LXH·April 16, 2024
CA090, DIRECT DRIVE LCA 3/BX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL·Product code FZP·November 25, 2014
CA090, DIRECT DRIVE LCA 3/BX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL·Product code FZP·November 25, 2014
STRYKEFLOW2 WITH DISPOSABLE TIP (6BX)
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code LJH·November 3, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·August 17, 2011
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 11, 2013
THORATEC® HEARTMATE 3® LVAS IMPLANT KIT
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·December 18, 2025
VIDAS® ESTRADIOL II
FDA Adverse Event
Malfunction
·BIOMÉRIEUX SA·Product code CHP·May 15, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024