15 results
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43ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COBAS C BILIRUBIN TOTAL GEN.3
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776402471·Corkscrew T-Handle, Diameter 10mm, 11" OL
HEATER COOLER UNIT, MODEL HCU 30
FDA 510(k)
FDA Class 2
·Cardiovascular
GLIDER PTCA BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
BELLATEK® LAB DESIGNED ZIRCONIA ABUTMENT
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·October 1, 2014
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·May 16, 2013
SUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011
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
ELECSYS TSH ASSAY
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JLW·November 9, 2020
TFNA FEM NAIL Ø11 R 130° L360 TIMO15
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HSB·February 23, 2023
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
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