20 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383508001·Gutta Percha Points is used to root canal filin...
XENX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
AXIOS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024
AXIOS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·February 19, 2025
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 21, 2020
AXIOS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 17, 2024
AXIOS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·February 20, 2025
AXIOS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 8, 2014
ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·June 8, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011
Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·May 16, 2018
AXIOS?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024
SURGIQUEST AIRSEAL
FDA Adverse Event
Injury
·SURGIQUEST, INC.·Product code GCJ·September 25, 2014
AXIOS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 27, 2024
SURGIQUEST AIRSEAL
FDA Adverse Event
Injury
·SURGIQUEST, INC.·Product code GCJ·March 11, 2015
SURGIQUEST AIRSEAL
FDA Adverse Event
Other
·SURGIQUEST, INC.·Product code HIF·December 12, 2013
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023