10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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High Speed Handpieces and Accessories
FDA 510(k)
FDA Class 1
·Dental
XHIBIT CENTRAL STATION, MODEL 96102
FDA 510(k)
FDA Class 2
·Cardiovascular
BAHADIR STERILIZATION TRAYS
FDA 510(k)
FDA Class 2
·General Hospital
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 8, 2014
PELVICOL ACELLULAR COLLAGEN MATRIX
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTL·May 21, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·July 7, 2011
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Hemospray Endoscopic Hemostat
FDA Recall
Terminated
·Wilson-Cook Medical Inc.·Product code QAU·July 24, 2019
Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy.
FDA Recall
Terminated
·Wilson-Cook Medical Inc.·Product code KNS·January 4, 2019
Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707
FDA Recall
Terminated
·Cook Medical Llc·Product code MQG·December 16, 2020