14 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
STAR 50 N
FDA 510(k)
FDA Class 2
·Cardiovascular
C.T.M. POWER CHAIR, MODEL HS-1500
FDA 510(k)
FDA Class 2
·Physical Medicine
REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTD·October 6, 2020
TRUWAVE, VAMP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·March 20, 2025
ACTIVA
FDA Adverse Event
Malfunction
·IPG MFG SWITZERLAND·Product code MRU·June 17, 2013
FINELINE II
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·July 23, 2011
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·September 25, 2008
TRUWAVE, VAMP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code KRA·April 18, 2025
REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTD·February 17, 2021
TRUWAVE, VAMP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·March 20, 2025
Alere iScreen Dx Urine Drug Screen Card
FDA Enforcement
Class III
·Terminated·Ameditech Inc·May 9, 2018
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012