21 results
·
23ms
·
Sources: EU EUDAMED, US FDA
MOBILEDIAGNOST WDR
FDA 510(k)
FDA Class 2
·Radiology
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365102967·
C2 LATERAL. FEMORAL STEM # 2
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code LZO·September 5, 2019
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311117250·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321117250·
Rhythmlink®
FDA UDI
RHYTHMLINK INTERNATIONAL, LLC·00816312024715·50 Monopolar Needle Electrodes, EMG, 25mm x 27g
Chalgren
FDA UDI
CHALGREN ENTERPRISES·00816020020115·Monopolar Needle Electrode, EMG, 25mm x 27g
OLYMPUS SUCTION PUMP, MODEL KV-5
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TRIGEN LOW PROFILE BONE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
CADD SOLIS VIP PUMPS
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·June 3, 2022
CADD-SOLIS VIP AMBULATORY INFUSION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·August 18, 2022
W1-SS-111725
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Ze Fang Technology Co., Ltd.·1 device
OPLUM A+ PUMP DRIVER
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD·Product code FRN·May 7, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014
MEDPOR IMPLANT
FDA Adverse Event
Injury
·STRYKER CRANIOMAXILLOFACIAL GEORGIA·Product code FWP·June 2, 2011
TRI-STAPLE 2.0
FDA Adverse Event
Malfunction
·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·February 13, 2024
LIBRE 2 SENSOR FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code QLG·February 9, 2024
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·December 9, 2015
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
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