10 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SPI DENTAL IMPLANT ABUTMENTS
FDA 510(k)
FDA Class 2
·Dental
PALOMAR LC 100 DIODE LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDIS 2MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ARCOM XL 44-36 STD HMRL BRNG
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWS·April 2, 2013
CODEMASTER XL+
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code LDD·March 21, 2011
KAPPA DR 400
FDA Adverse Event
Injury
·MEDTRONIC INC·Product code DXY·April 15, 2008
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