17 results
·
20ms
·
Sources: EU EUDAMED, US FDA
WILDCAT 7F GUIDEWIRE SUPPORT CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Zavation
FDA UDI
Zavation LLC·00842166177338·Z-Link Lumbar Sizer 8 deg, 33mm x 13
Zavation
FDA UDI
Zavation LLC·00842166112315·Z-Link Lumbar Spacer 8deg 33mmx13
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·August 6, 2024
QUATRO M FEMORAL COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
FILAC FAS TEMP ELECTRONIC THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
PLATE, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HRS·November 16, 2015
4.0MM CANCELLOUS BONE SCREW PARTIALLY THREADED/45MM
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HWC·December 9, 2015
M2A-MAGNUM 42-50MM TPR INSRT-3
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·April 29, 2013
GUIDEWIRE
FDA Adverse Event
Malfunction
·GALT MEDICAL CORP.·Product code DQX·April 13, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 25, 2008
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·September 1, 2016
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·December 4, 2015
4.0MM CANCELLOUS BONE SCREW FULLY THREADED/45MM
FDA Adverse Event
Injury
·SYNTHES GRENCHEN·Product code HWC·December 18, 2015
BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018