13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825
FDA 510(k)
FDA Class 2
·Cardiovascular
BAUMER FEMORAL HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE
FDA 510(k)
FDA Class 2
·Anesthesiology
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·July 25, 2018
PREFYX PPS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code FTL·April 2, 2013
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·March 21, 2011
COSGROVE-EDWARDS ANNULOPLASTY SYSTEM
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·April 18, 2008
DYNESYS LIS, STABILIZING CORD, 200
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code NQP·May 2, 2019
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR·Product code DQX·September 30, 2022
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