12 results · 28ms · Sources: EU EUDAMED, 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