14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MULTIMICRO SURGICAL CAUTERY
FDA 510(k)
FDA Class 2
·Ophthalmic
Greenwald Surgical Company, Inc.
FDA UDI
GRACE MANUFACTURING, INC.·10801334012298·McCrea Female Sound, Curved. 3/4-inch nominal b...
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100120·Counter Torque, Offset
ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10
FDA 510(k)
FDA Class 1
·Microbiology
LC PROVIFILL
FDA 510(k)
FDA Class 2
·Dental
ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM
FDA Adverse Event
Malfunction
·ZYNO MEDICAL, LLC·Product code FPA·December 9, 2020
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 25, 2014
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code LFL·November 12, 2007
LAP-BAND ACCESS PORT KIT (UNK SIZE)
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·October 23, 2012
ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·April 8, 2021
BD¿ IV SET BN311 W/O PUMP T-TYPE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·December 27, 2019
Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·July 13, 2016
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024