12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VariAx 2 Distal Radius System
FDA 510(k)
FDA Class 2
·Orthopedic
CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS
FDA 510(k)
FDA Class 2
·Ophthalmic
CONSENSUS VITALITE TIBIAL INSERT
FDA 510(k)
FDA Class 2
·Orthopedic
BD MICRO-FINE¿ U-40 INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·June 5, 2018
WALLFLEX ESOPHAGEAL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 16, 2025
WALLFLEX ESOPHAGEAL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 23, 2025
WALLFLEX ESOPHAGEAL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 14, 2025
SCORPIO-FLEX PS X3 TIB INSERT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code HSH·November 14, 2008
CANE, CRUTCH AND WALKER TIPS AND PADS
FDA Adverse Event
UNKNOWN·Product code INP·September 6, 2011
QUATROLOC FEM REV STEM W/O LATERAL SHOULDER
FDA Adverse Event
Injury
·WHITESIDE BIOMECHANICS (NOW SIGNAL MEDICAL)·Product code LPH·July 16, 2013
WALLFLEX ESOPHAGEAL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code ESW·May 28, 2025
Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·February 14, 2024