17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TOSHIBA 1.5T QD HEAD COIL
FDA 510(k)
FDA Class 2
·Radiology
24M - 16 person Class A First Aid/Burn Kit
FDA UDI
Certified Safety Manufacturing, Inc.·00766588206271·24M - 16 person Class A First Aid/Burn Kit
VENTED AUTOFEED CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·June 11, 2013
VENTED AUTOFEED CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 3, 2012
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-GATIFLOXACIN
FDA 510(k)
FDA Class 2
·Microbiology
NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·May 20, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 26, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 10, 2011
EAGLE EYE PLATINUM SHORT TIP
FDA Adverse Event
Injury
·VOLCANO CORPORATION·Product code OBJ·July 1, 2016
EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER
FDA Adverse Event
Injury
·VOLCANO CORPORATION·Product code OBJ·July 1, 2016
EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER
FDA Adverse Event
Injury
·VOLCANO CORPORATION·Product code OBJ·July 1, 2016
EVOLUT FX PLUS VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·August 14, 2025
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
VENTED AUTOFEED CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 11, 2013
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
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021