12 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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POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND GREEN COLORED
FDA 510(k)
FDA Class 1
·General Hospital
BALANCE MIDDLE WEIGHT UNIVERSAL GUIDEWIRE
FDA Adverse Event
Injury
·GUIDANT CORP·Product code DQX·July 27, 2007
XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·April 2, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 28, 2011
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code MUZ·March 18, 2008
DYNESYS LIS, STABILIZING CORD, 200
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code NQP·May 2, 2019
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