10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENDOVASCULAR LASER VEIN SYSTEM KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·August 31, 2022
MODIFICATION TO: STRAIGHT POST AND CORE II FOR THE BASIC DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
CPR FACE MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
UNKNOWN
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·December 15, 2015
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·May 14, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·September 23, 2014
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·April 6, 2011
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025