27 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SMV Scientific 4.5 mm Bone Screws
FDA 510(k)
FDA Class 2
·Orthopedic
DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT
FDA 510(k)
FDA Class 2
·Hematology
EPIGUARD
FDA 510(k)
FDA Class 2
·Neurology
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·July 21, 2017
RADICAL-7 HANDHELD
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·November 18, 2014
RADICAL-7 HANDHELD
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·November 18, 2014
RADICAL-7 HANDHELD
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·November 18, 2014
RADICAL-7 HANDHELD
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·November 18, 2014
RADICAL-7 HANDHELD
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·November 18, 2014
RADICAL-7 HANDHELD
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·November 18, 2014
RADICAL-7 HANDHELD
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·November 18, 2014
RADICAL-7
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·February 19, 2016
SEDLINE KIT
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code MWI·January 8, 2017
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·October 7, 2014
UPHOLD VAGINAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 6, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011
RADICAL-7
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·July 9, 2015
SEDLINE KIT
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code GWQ·July 21, 2017
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
MICROVASCULAR PLUG
FDA Adverse Event
Injury
·REVERSE MEDICAL·Product code KRD·September 8, 2021