10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TraumaCad Neo (1.1)
FDA 510(k)
FDA Class 2
·Radiology
AETREX WORLDWIDE, INC.
FDA registration
AETREX WORLDWIDE, INC.·1 product·🇺🇸 United States
Portrait VSM
FDA 510(k)
FDA Class 2
·Cardiovascular
Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 9, 2023
BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code FMI·March 18, 2024
ONE TOUCH ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·November 24, 2008
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 12, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 23, 2013
PKG, PKG, HOOK SCISSORS, P/N 0250080260. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014