20 results · 26ms · Sources: EU EUDAMED, 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