12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CueSee Hypoxic
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106358·MOODY FIXATION FORCEPS - LEFT
MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
NITOM LOCKING FACEBOW
FDA 510(k)
FDA Class 2
·Dental
WALLSTENT RP ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MAF·April 19, 2023
STYLE 68 SALINE FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FWM·March 5, 2020
SYMBIQ SCHANNEL 3.01
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·October 6, 2014
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DTQ·June 27, 2011
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 7, 2013
CRIT-LINE BLOOD CHAMBER
FDA Adverse Event
Malfunction
·CONCORD MANUFACTURING·Product code KOC·July 21, 2018
WALLSTENT? RP ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 21, 2025
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023