12 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Okti
FDA 510(k)
FDA Class 2
·Neurology
EVONOS
FDA UDI
Gyrus ACMI, LLC·00821925028333·SHEA BELLUCI SCISSORS CURVED RIGHT
Intrigue
FDA UDI
LANCER ORTHODONTICS, INC.·00817573020201·INTRG WHISP-Z ROTH 2BIC -22T 0A 018 LO
MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS
FDA 510(k)
FDA Class 2
·Orthopedic
VERMED A10021 RESTING EKG TAB ELECTRODE
FDA 510(k)
FDA Class 2
·Cardiovascular
Widex
FDA UDI
Widex A/S·05706069691382·Widex BEYOND B-F2 (Titan grey ) 330, Telecoil, ...
DURAL ALPHA INSERT NEUTR KK/28
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·January 2, 2026
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 11, 2014
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·August 31, 2011
7.0MM TI CANNULATED MATRIX SCREW 40MM THREAD LENGTH
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code NKB·July 16, 2013
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only
FDA Enforcement
Class II
·Ongoing·UIH Technologies LLC·October 29, 2025
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025