7 results
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10ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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 Recall
Terminated
·Maquet Cardiopulmonary Ag Kehler Strasse 31 Rastatt Germany·Product code KRI·April 4, 2018
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
Rocket KCH Fetal Bladder Drainage Catheter Model: R57405
FDA Recall
Terminated
·Rocket Medical Plc Industrial Estate Sedling Road Wear Indu Tyne & Wear Washington United Kingdom·Product code MPR·August 1, 2019
Rocket KCH Fetal Bladder Drainage Catheter Model: R57405
FDA Enforcement
Class II
·Terminated·Rocket Medical Plc·December 4, 2019
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004
FDA Enforcement
Class II
·Terminated·Kelyniam Global, Inc.·May 23, 2018
Microfil Composite Instruments are packaged in an unsealed plastic sleeve, which is then placed in a cardboard box. Microfil Composite Instruments are intended to be sterilized by the dentist prior to each use. It is used for composite restoration development. The thin paddles shape light-cured composites. Paddles slide under the gum line to shape the margin. The flat ends contour the surfaces of the teeth and the thin edge is used to create esthetic highlights. Models: #96041 Gold Microfil #96042 Green Microfil #96043 Blue Microfil #96044 Set of 3 Microfil (Gold, Green, Blue)
FDA Recall
Terminated
·Almore International Inc·Product code EKH·April 20, 2017
Roche/Hitachi ALT (ALAT/GPT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P Module; Catalog number 1877470 (11877470216).
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code CKH·August 20, 2004