9 results
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22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CERALAS D10 810NM LASER, MODEL CERALAS D10-60
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HORIZON OUTLOOK WITH DOSECOM
FDA 510(k)
FDA Class 2
·General Hospital
RADIFOCUS GLIDEWIRE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·April 9, 2013
THERAPY COOL PATH ABLATION CATHETER
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, IRVINE·Product code OAD·March 31, 2011
ENDOTAK RELIANCE G
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS·Product code LWS·May 8, 2008
BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Company·November 26, 2025
C8701, S ALEXIS LAP SYS W/ KII FIOS 5/BX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code GCJ·November 14, 2016
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018