11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450193235·
UTA AND UHA
FDA 510(k)
FDA Class 2
·Dental
SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TORNIER
FDA Adverse Event
Malfunction
·TORNIER INC.·Product code HWC·April 8, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 20, 2013
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Other
·INVACARE·Product code ITI·June 3, 2011
VERSE POLY DRIVER SHAFT NAV
FDA Adverse Event
Malfunction
·DEPUY SPINE INC·Product code OLO·April 29, 2022
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult ClearSeal Flexible King LAD¿ Patient Size: 50-70kg " Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015