9 results
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22ms
·
Sources: EU EUDAMED, US FDA
JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123
FDA 510(k)
FDA Class 2
·Microbiology
REPROCESSED SOFT TISSUE ABLATORS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG
FDA 510(k)
FDA Class 2
·Neurology
MULTI-RADIOFREQUENCY MODULE
FDA Adverse Event
Malfunction
·BAYLIS MEDICAL CO., INC.·Product code GXD·April 19, 2013
SPEEDBAND SUPERVIEW SUPER 7, MODELS 4204
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code MND·April 29, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008
MANTIS REDUX BLOCKER
FDA Adverse Event
Malfunction
·STRYKER SPINE-US·Product code NKB·November 27, 2019
SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012