5 results
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6ms
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Sources: EU EUDAMED, US FDA
CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 Product Usage: The Cardiohelp Gas Bottle (or Cylinder) Holder HKH 8880 is an accessory for the CARDIOHELP System and required for inter-hospital patient transport in aircraft and road vehicles (mobile intensive care units and ambulances). Inter-hospital patient transport is transport of the patient between clinics, where the clinical environment is left (e.g., transport in vehicles such as ambulances or aircraft). The gas cylinder holder serves to hold an oxygen cylinder in aircraft.
FDA Enforcement
Class II
·Terminated·Maquet Cardiopulmonary Ag·May 16, 2018
TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Catalog # 5541-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB).
FDA Enforcement
Class II
·Terminated·Howmedica Osteonics Corp.·October 9, 2019
BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use.
FDA Enforcement
Class II
·Terminated·JK Products & Services, Inc·August 22, 2012
SUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet Radiation. The device is intended to be used for tanning of the human skin.
FDA Enforcement
Class II
·Terminated·JK Products & Services, Inc·September 19, 2012
SUN DASH RADIUS 252 PN 8000809705. The device is intended to be used for the tanning of human skin.
FDA Enforcement
Class II
·Terminated·JK Products & Services, Inc·September 24, 2014