11 results
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19ms
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Sources: EU EUDAMED, US FDA
CLASSIC TAN TANNING BOOTH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NUPRO® Sensodyne® Prophylaxis Paste with Fluoride and NovaMin®
FDA UDI
DENTSPLY INTERNATIONAL INC.·D0038015211·NUPRO® Sensodyne® Prophy Paste, Citrus Mint, St...
Symmetry Verity™
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482030974·Verity Scissors, Curved, Fine Tip, 168 mm
EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.
FDA Enforcement
Class II
·Terminated·Dako North America Inc.·November 11, 2015
MODIFICATION TO HAMILTON-G5
FDA 510(k)
FDA Class 2
·Anesthesiology
SOFTSENS
FDA 510(k)
FDA Class 2
·Neurology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 16, 2007
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 23, 2012
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022