11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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F&P 950 Accessory Breathing Circuit Kits
FDA 510(k)
FDA Class 2
·Anesthesiology
Steril Peel
FDA UDI
AMD Medicom Inc·D830221436·STERIL-PEEL TUBING/ROLL 6" X 100'
TTECH MODEL 200E + TENS DEVICE
FDA 510(k)
FDA Class 2
·Neurology
DAS MEDICAL EQUIPMENT DRAPES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 3, 2014
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·August 16, 2011
HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·July 9, 2013
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·April 28, 2023
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·March 14, 2023
SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·June 30, 2022
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020