30 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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MODIFICATION TO SYNTHES USS
FDA 510(k)
FDA Class 2
·Orthopedic
Silverbolt/Mainframe
FDA UDI
Choice Spine, LP·10885862161208·
APEX Spine System
FDA UDI
SPINECRAFT, LLC·00193082003998·APEX Ti Straight Rod Dia.6.00, 450mm
Stryker
FDA UDI
Provision·B504OM0210004500·
Golden Isles Pedicle Screw System
FDA UDI
Intelivation, LLC·G079C2520004500·Curved Ti Rod, 450mm
PenEvac1
FDA UDI
I.C. MEDICAL, INC.·00817688020011·
TOP QUALITY CHLORINATED-POWDERFREE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
CAUTERY FORCEPS WITH FOOTSWITCH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/10 MM R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 9, 2021
Clarius Ultrasound Scanner
FDA UDI
Clarius Mobile Health Corp·07540205000014·
ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code LIT·March 12, 2013
COMPLETE SE PERIPHERAL STENT SYSTEM
FDA Adverse Event
Death
·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code NIO·February 18, 2011
PUMP MMT-522LNAL PRDGM INS CL EN ML
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·February 21, 2008
MEDTRONIC TRANSCATHETER VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·March 25, 2021
TECNIS SIMPLICITY
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code HQL·February 21, 2025
SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·May 23, 2018
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