18 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER
FDA 510(k)
FDA Class 2
·Neurology
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1100510·Caddie, 5.5mm Screws
MYSTIQUE® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K110151101·MYSTIQUE® MB RT RX 018 U 5-5 CS HK
VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR
FDA 510(k)
FDA Class 2
·Radiology
BPFONE, MODEL UA 767IT
FDA 510(k)
FDA Class 2
·Cardiovascular
RX ACCUNET EMBOLIC PROTECTION SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NFA·October 15, 2007
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 10, 2024
RX ACCULINK CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NIM·October 15, 2007
RX ACCULINK CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NIM·October 15, 2007
BD LUER SLIP¿ TUBERCULIN SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMF·February 8, 2018
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL- NEUROMODULATION·Product code LGW·May 9, 2013
SURGUARD2 SAFETY NEEDLE
FDA Adverse Event
Malfunction
·TERUMO PHILIPPINES CORPORATION·Product code MEG·September 23, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·June 1, 2011
SYRINGE 5ML LL TIP BULK CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·January 27, 2021
Ingenia 1.5T and 3.0T MRI Systems, Model Numbers: 781396 and 781377, 510(k) #K110151. System units equipped with software version: 4.1.1 are subject to recall/field correction. This MRI system is indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities. Image appearance is determined by the spatial distribution and flow as well as by many different NMR related properties of the tissue and anatomy studied and the MRI scan technique applied. These images and/or spectra, when interpreted by a trained physician, provide information that may assist the diagnosis.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code LNH·August 3, 2011
MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.
FDA Enforcement
Class II
·Terminated·Medrad Inc·February 27, 2013
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
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024