16 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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STRYKER L3 HYDROLERT
FDA 510(k)
FDA Class 2
·General Hospital
Safco polycarbonate crowns
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310222483·Safco polycarbonate crowns #301 5/box
B-P TOTAL SHOULDER SYSTEM
FDA UDI
ENDOTEC, INC.·00814193025098·B-P SHOULDER GLENOID BEARING SIZE 2, 2.5 MM THI...
CHASE CARDIOVASCULAR PATCH
FDA 510(k)
FDA Class 2
·Cardiovascular
DINAMAP PRO 1000 MONITOR, MODEL 1000
FDA 510(k)
FDA Class 2
·Cardiovascular
BD LUER-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·April 11, 2026
BD LUER-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·April 11, 2026
SYNREAM FLEXSHAFT
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HTO·March 26, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 28, 2011
GUIDANT VASO VIEW HEMOPRO
FDA Adverse Event
Malfunction
·GUIDANT CARDIAC SURGERY·Product code GEI·March 26, 2008
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·December 14, 2021
STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
FDA Enforcement
Class II
·Terminated·Diagnostica Stago, Inc.·November 14, 2012
AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.
FDA Enforcement
Class II
·Terminated·Vision RT Ltd·August 31, 2016
TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.
FDA Enforcement
Class II
·Terminated·Vision RT Ltd·August 31, 2016
Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172
FDA Enforcement
Class II
·Terminated·Vision RT Ltd·October 10, 2018
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Enforcement
Class II
·Terminated·Welch Allyn Protocol, Inc·January 15, 2014