11 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
RESPONSE Spine System, RESPONSE 4.5/5.0 Spine System, RESPONSE 5.5/6.0 Spine System
FDA 510(k)
FDA Class 2
·Orthopedic
CHIMAERA HIP FRACTURE SYSTEM
FDA UDI
ORTHOFIX SRL·18054242515593·TARGETING HANDLE
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702421613·Elvarex 3/Thigh High/Slant-Open Toe/Thigh high ...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702829167·ELVAREX 3/KNEE HIGH/CLOSED TOE-ELEPHANTIASIS-VE...
MOUNTAINEER OCT SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA)
FDA 510(k)
FDA Class 2
·Physical Medicine
OMNIFIX®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FMF·March 6, 2026
ISERT ASPHERIC INTRAOCULAR LENS
FDA Adverse Event
Malfunction
·HOYA SURGICAL OPTICS INC.·Product code HQL·July 21, 2011
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 6, 2008
HUDSON SPIRAL-FLEX ENDOTRACHEAL TUBE, 7.5MM
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTR·June 21, 2013
BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020