29 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I CALIBRATION VERIFICATION MATERIAL, 2000 PROLACTIN C
FDA 510(k)
FDA Class 1
·Clinical Chemistry
icotec Cervical Cage, Anatomic Probe, 8 mm x 18 mm
FDA UDI
icotec AG·07640140438931·icotec Cervical Cage, Anatomic Probe, 8 mm x 18 mm
ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920
FDA 510(k)
FDA Class 1
·Microbiology
MEDLINE STRIDER MINI 3
FDA 510(k)
FDA Class 2
·Physical Medicine
CADD ADMINISTRATION SET
FDA Adverse Event
Malfunction
·ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V·Product code FPA·March 26, 2026
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
HARMONIC ACE
FDA Adverse Event
Malfunction
·STRYKER SUSTAINABILITY SOLUTIONS·Product code LFL·May 31, 2013
INSULIN INFUSION PUMP
FDA Adverse Event
Death
·MEDTRONIC MINIMED·Product code OYC·October 3, 2014
STAIR PRO - MODEL 6252
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPP·May 31, 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