15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC
FDA 510(k)
FDA Unclassified
·Unknown
DELTEX MEDICAL CARDIOQ EDM
FDA 510(k)
FDA Class 2
·Cardiovascular
HEADWAY 17 ADVANCED MICROCATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
STEM: AMISTEM H HA COATED STD STEM SIZE 2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 24, 2024
PACKER/CHANG IOL CUTTER
FDA Adverse Event
Malfunction
·MICROSURGICAL TECHNOLOGY, INC.·Product code HNF·May 16, 2013
THERMACHOICE
FDA Adverse Event
Injury
·ETHICON·Product code MNB·June 16, 2011
PULSE GEN MODEL 106
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·October 1, 2014
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
AMISTEM H SIZE 2 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 8, 2013
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