13 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ONE DIMENSIONAL WATER PHANTOM, WP 1D
FDA 510(k)
FDA Class 2
·Radiology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032594·Baltic Denture System BDLoad Mm6 PLSEbim6DFm D2...
PLAYTEX BREAST PUMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TENO FIX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OASYS BLOCKER
FDA Adverse Event
Injury
·STRYKER SPINE-FRANCE·Product code KWP·November 30, 2015
5X100MM KII SLEEVE ADVANCED FIXATION 12/BX
FDA Adverse Event
APPLIED MEDICAL·Product code GCJ·March 29, 2013
TI PARALLEL CONNECTOR
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MDI·March 23, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code NIQ·April 21, 2008
ARCHITECT CA 19-9XR
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code NIG·April 27, 2017
ARCHITECT CA 19-9XR
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code NIG·April 27, 2017
ARCHITECT CA 19-9XR
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code NIG·April 27, 2017
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