11 results
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19ms
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Sources: EU EUDAMED, US FDA
DIAMOND SETUP 2000
FDA 510(k)
FDA Class 2
·Radiology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032886·Baltic Denture System BDLoad Mw7 PLSEbim6DFm B2...
CBYON SYSTEM WITH IMAGE ENHANCED FLUOROSCOPY MODULE
FDA 510(k)
FDA Class 2
·Neurology
IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
11.0 CM LONG ATTACHMENT
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·March 29, 2013
SPRINT FIDELIS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 29, 2011
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·April 23, 2008
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
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012