15 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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STRONG Dental Handpieces
FDA 510(k)
FDA Class 1
·Dental
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704512526·
PFT Kit A, 28MM O.D
FDA UDI
A-M SYSTEMS, LLC·00817081027877·Pulmonary Function Test Kit A, 28MM O.D., W/Foa...
ONE TOUCH BASIC
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·January 9, 2002
ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
ENSEAL POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, ETRIO-314D,-325D,-335D,-345D, ENSEAL UNIVERSAL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPECTRA WAVEWRITER?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 13, 2025
GROSHONG NXT CLEARVUE 4 FR SINGLE LUMEN, BASIC T
FDA Adverse Event
Injury
·C.R. BARD, INC. (BASD)·Product code LJS·July 22, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 21, 2013
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code NIQ·September 30, 2008
6MM/9MM CANNULATED STEPPED DRILL BIT
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HTW·December 1, 2020
UNK - NAIL INSERTION HANDLES
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code LXH·March 9, 2020
Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405198) Product Usage: The device is designed to provide regional anesthesia. The device may contain syringes, needles and drugs
FDA Enforcement
Class II
·Terminated·Kimberly-Clark Corporation·December 25, 2013
Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781347
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
ROSA Brain 3.0 Application-Brain
FDA Enforcement
Class II
·Terminated·MEDTECH SAS·February 19, 2020