10 results
·
29ms
·
Sources: EU EUDAMED, US FDA
VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HEC 1000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AMISTEM H FEMORAL STEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 2, 2013
OT VERIO IQ 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
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient Size: 30-50kg " 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
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023