11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GLOBAL MODULAR REPLACEMENT SYSTEM ANTEVERTED PROMIMAL FEMORAL COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032581·Baltic Denture System BDLoad ↓ Mw7 PLSEum2DFm D...
DURAGARD SODIUM FLUORIDE VARNISH
FDA 510(k)
FDA Class 2
·Dental
REPROCESSED STONE RETRIEVAL BASKETS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COMP RVS HMRL TI TRAY 44MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code PAO·December 31, 2014
GENTLECATH INTERMITTENT URINARY CATHETER
FDA Adverse Event
Other
·CONVATEC·Product code KOD·April 1, 2013
11MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT-STER
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HSB·March 23, 2011
CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code JIX·April 21, 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
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013