12 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AquaBeam Robotic System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112540·BARRON VACUUM TREPHINE 8.75MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112960·CORNEAL TREPHINE BLADE8.75MM
RTDOSEPLAN
FDA 510(k)
FDA Class 2
·Radiology
MINITUB MULTI-PURPOSE CASSETTES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·October 27, 2014
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MPRI·Product code DTB·July 2, 2013
RICKHAM RESERVOIR
FDA Adverse Event
Injury
·JOHNSON AND JOHNSON PROFESSIONAL, INC. / MEDOS S.A·Product code JXG·November 20, 2015
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EGS·May 28, 2023
VENT RES TR RICKHAM LG BA
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code JXG·May 15, 2015
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