8 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVAL
FDA 510(k)
FDA Class 2
·Neurology
STELLAR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LEFT A/S BROACH HANDLE
FDA Adverse Event
Other
·GREATBATCH MEDICAL, INC.·Product code HTQ·April 26, 2013
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 2, 2011
PUMP MMT-722LNAS PRDGM INS SK EN ML
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·August 1, 2008
smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060JP; c) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070; d) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070JP; e) AIRWAY NASOPHARYNGEAL 8.0MM, REF 100/210/080; f) AIRWAY NASOPHARYNGEAL 8.0MM, REF 100/210/080JP; g) AIRWAY NASOPHARYNGEAL 8.0MM, REF 100/210/080JS; h) AIRWAY NASOPHARYNGEAL 9.0MM, REF 100/210/090; i) AIRWAY NASOPHARYNGEAL 9.0MM, REF 100/210/090JP;
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·October 30, 2024
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