14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES
FDA 510(k)
FDA Class 2
·Cardiovascular
BD 60ML SYRINGE LUER-LOK TIP
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·September 22, 2020
CALCIUM SULFATE PELLETS
FDA 510(k)
FDA Class 2
·Orthopedic
ASCENT ALL-POLY PS TIBIAL BEARINGS
FDA 510(k)
FDA Class 2
·Orthopedic
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·April 2, 2013
CCU BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 21, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 22, 2014
BD PHOENIX¿ PMIC-108
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 25, 2024
BD PHOENIX¿ PMIC-108
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 19, 2024
2710 CLEARTRACE LT
FDA Adverse Event
Other
·CONMED CORPORATION·Product code GXY·April 13, 2007
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
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016