14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CHEMOLOCK, CHEMOLOCK PORT
FDA 510(k)
FDA Class 2
·General Hospital
40" (102 CM) APPX 5.3 ML ADMIN SET W/2 CHEMOLOCK¿
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·June 13, 2025
SOLID STATE LAMP [LED] HEADLIGHT
FDA 510(k)
FDA Class 2
·Ophthalmic
ATTUNE SLEEP APNEA SYSTEM
FDA 510(k)
FDA Class 2
·Dental
CARPENTIER-EDWARDS PERIMOUNT® RSR PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·October 1, 2014
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 16, 2013
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·June 16, 2011
QUATERA 700 BIMANUAL I/A HANDPIECE SET
FDA Adverse Event
Injury
·CARL ZEISS MEDITEC AG (OBERKOCHEN)·Product code FSO·September 8, 2023
ROD, FIXATION, INTRAMEDULLARY
FDA Adverse Event
Injury
·SYNTHES USA·Product code HSB·May 4, 2016
ROD, FIXATION, INTRAMEDULLARY
FDA Adverse Event
Injury
·SYNTHES USA·Product code HSB·May 4, 2016
ROD, FIXATION, INTRAMEDULLARY
FDA Adverse Event
Injury
·SYNTHES USA·Product code HSB·May 4, 2016
TFNA FEM NAIL Ø11 R 130° L360 TIMO15
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HSB·February 23, 2023
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·April 5, 2018
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015