26 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CYNOSURE PHOTOGENICA VLS-STAR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Sledgehammer
FDA UDI
Keystone Industries·H66810004901·SC 25 lb Pwd & 4 Qt Liq Kit, Clear
Nobel
FDA UDI
Preat Corporation·00842092100868·NobelBiocare™ Tri-Lobe-compatible NP Snappy Abu...
Silverbolt/Mainframe
FDA UDI
Choice Spine, LP·10885862161260·
OptiMesh Multiplanar Expandable Interbody Fusion System
FDA UDI
SPINEOLOGY INC.·M7401000490·5.5mm Rod Hand Brace
CURE™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167700004900·
Golden Isles Pedicle Screw System
FDA UDI
Intelivation, LLC·G079C2520004900·Curved Ti Rod, 490mm
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 2, 2024
CURE™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167S1700004900·
MODIFICATION TO CARTO EP NAVIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
GUTHRIE PRIME POWDER-FREE CHLORINATED PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
PWRD ECH FLEX 45MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·March 12, 2013
INRATIO2
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·January 31, 2011
DLP-W11
FDA Adverse Event
Other
·UTAH MEDICAL PRODUCTS, INC.·Product code KNS·January 24, 2008
BAXJECT II HI-FLOW NEEDLESS TRANSFER DEVICE
FDA Adverse Event
Malfunction
·TAKEDA PHARMACEUTICALS U.S.A., INC.·Product code LHI·May 4, 2026
BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015
BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013
Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD, Inc.·August 8, 2012
BrightView, Gamma Camera System, Product Code 882480.
FDA Enforcement
Class II
·Ongoing·Philips North America·January 17, 2024
BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 9, 2016