19 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
ARGEDENT 40SF (5 dwt)
FDA UDI
ARGEN CORPORATION, THE·D818120173·Gold based noble metal
Frame Carrier Breast BI 7 meidal
FDA UDI
Noras MRI products GmbH·04251269205637·
Diversatek Healthcare
FDA UDI
DIVERSATEK HEALTHCARE, INC.·M7831201730·Endoscopy Basic Procedure Kit w/o Suction Tubing
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319720127·Gruenwald (Jansen) Dressing Forceps 7-1/2" (19c...
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 9, 2021
ID NOW COVID-19
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·August 6, 2020
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH INC.·Product code QJR·April 6, 2021
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197031776·Davis Facelift Scissors
curved...
IYUNNI 3ID TRI-FUNNEL FEEDING TUBE KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TETRACYCLINE (0.12-128 UG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
POWERPACK
FDA Adverse Event
Malfunction
·ICC-NEXERGY·Product code IYN·September 3, 2013
ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM
FDA Adverse Event
Injury
·CORDIS CORPORATION·Product code NTE·May 20, 2013
GORE® TAG® THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·September 25, 2014
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SHERBROOKE·Product code BRZ·June 10, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Other
·INVACARE·Product code ITI·March 9, 2011
Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
FDA Enforcement
Class II
·Ongoing·AURIS HEALTH INC·October 16, 2024
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
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021