9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NOVA CHEMISTRY CONTROLS, LEVEL 1,2,AND 3 W/O CREAT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
G.E. POLARIX II C-ARM
FDA 510(k)
FDA Class 2
·Radiology
Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)
FDA 510(k)
FDA Class 1
·General Hospital
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 23, 2014
INFERIOR END PLATE MEDIUM-STERILE
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MJO·February 15, 2013
IRIS SUPERCUT SCISSOR
FDA Adverse Event
Malfunction
·AESCULAP, INC.·Product code LRW·January 6, 2011
STEALTH 32 LHOOK LAP ELEC PKG
FDA Adverse Event
Malfunction
·CONMED UTICA·Product code GEI·November 12, 2021
STEALTH 32 LHOOK LAP ELEC PKG
FDA Adverse Event
Malfunction
·CONMED UTICA·Product code GEI·November 12, 2021
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026