12 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PIEZOTOME SOLO
FDA 510(k)
FDA Class 2
·Dental
CYBOW READER, MODELS 300 & 720
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CADD-LEGACY PLUS AMBULATORY INFUSION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·May 23, 2025
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 3, 2013
C-TAPER COCR LFIT HEAD 28MM/+5
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·July 7, 2011
ACCU-CHEK COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 16, 2008
PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT
FDA Adverse Event
Death
·SOPHYSA·Product code GWM·November 18, 2024
PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT
FDA Adverse Event
Malfunction
·SOPHYSA·Product code GWM·November 18, 2024
PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT
FDA Adverse Event
Malfunction
·SOPHYSA·Product code GWM·November 18, 2024
PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT
FDA Adverse Event
Malfunction
·SOPHYSA·Product code GWM·November 18, 2024
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024