16 results
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41ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014607177·SKYTRON 3500 4" SOFTCARE
General Instrument
FDA UDI
ALPHATEC SPINE, INC.·00840180504710·3x10mm Right Angled Pituitary w/ Scissor Style ...
MODIFICATION TO RTA RETINAL THICKNESS ANALYZER
FDA 510(k)
FDA Class 2
·Ophthalmic
M2376A DEVICELINK SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
RESPIRATORY HUMIDIFIER
FDA Adverse Event
Injury
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·August 9, 2011
INRATIO
FDA Adverse Event
Malfunction
·BIOSITE INCORPORATED·Product code GJS·December 21, 2009
INRATIO
FDA Adverse Event
Malfunction
·BIOSITE INCORPORATED·Product code JPA·November 14, 2009
AED PLUS
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 9, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 6, 2011
PULSE GEN MODEL UNK
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·July 18, 2008
ARCHITECT CYCLOSPORINE REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MKW·August 8, 2025
ARCHITECT CYCLOSPORINE REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MKW·September 4, 2025
ABBOTT TUBE EDTA PLH 13X75 2.0 PNK
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·August 3, 2022
ABBOTT TUBE EDTA PLH 13X75 2.0 PNK
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·September 17, 2019
ARCHITECT CYCLOSPORINE REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MKW·September 30, 2025