12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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S-MONOVETTE EDTA K2-GEL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MODIFICATION TO KSEA ENDOTIP SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DASH 3000/4000 PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
UNKNOWN ORTHOSIS
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code MNI·January 6, 2017
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·April 2, 2013
1-DAY ACUVUE TRUEYE NARAFILCON A
FDA Adverse Event
Injury
·VISTAKON·Product code LPL·March 23, 2011
20 FR GASTROSTOMY TUBE
FDA Adverse Event
Malfunction
·ROSS PRODUCTS DIVISION·Product code KNT·April 18, 2008
HARMONY DELIVERY CATHETER SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NPV·February 13, 2026
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
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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018