12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Stellar M22 for Intense Pulsed Light (IPL) and Laser System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EarQ
FDA UDI
Oticon A/S·05707131343819·G10, MINIRITE 312 2.4G C093 EARQ
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668101117·STEVENSON RETRACTOR 3X3 PRONGS
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702829204·ELVAREX 3/KNEE HIGH/SLANT-CLOSED TOE-ELEPHANTIA...
GORE EMBOLIC FILTER
FDA 510(k)
FDA Class 2
·Cardiovascular
POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE
FDA 510(k)
FDA Class 1
·General Hospital
MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·January 12, 2023
THERMACHOICE
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code MKN·October 8, 2008
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·June 27, 2013
PLM LFS PRIM PMP
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·July 21, 2011
Olympus Scientific Solutions Americas Corporation (OSSA) VANTA XRF Analyzer. Model Vanta VCR and Vanta VMR Analytical X-ray systems
FDA Recall
Terminated
·Olympus Scientific Solutions Americas·Product code RBY·January 7, 2017
Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - Product Usage: The HeartMate 3 Coring Tool is intended for use with the HeartMate 3 Left Ventricular Assist System (LVAS). The Coring Tool provides a means to resect a plug of myocardium from the left ventricle, which allows for HeartMate 3 inflow cannula insertion.
FDA Enforcement
Class II
·Terminated·Thoratec Corp.·May 1, 2019