29 results · 24ms · Sources: EU EUDAMED, US FDA

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ClariCT.AI

FDA 510(k)
FDA Class 2 ·Radiology

K-Systems

FDA UDI
Coopersurgical, Inc.·00888937025057·G85 Mini Incubator

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112595·BARRON CORNEAL PUNCH 7.0MM

NA

FDA UDI
Stryker Leibinger GmbH & Co. KG·07613153168492·BIPOLAR FORCEPS

BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·April 10, 2023

SYRINGE 50ML LL

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMF·October 25, 2023

SYRINGE 50ML LL

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMF·October 25, 2023

SYRINGE 50ML LL

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMF·October 25, 2023

SYRINGE 50ML LL

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMF·October 25, 2023

SYRINGE 50ML LL

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMF·October 25, 2023

XBO1-824-18/19/20 BIOPSY FORCEPS

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800

FDA 510(k)
FDA Class 2 ·Physical Medicine

BD PLASTIPAK¿ SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·April 11, 2023

BD PLASTIPAK¿ SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·April 10, 2023

TITAN

FDA Adverse Event
Injury ·COLOPLAST A/S·Product code FHW·May 22, 2023

CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code KRH·October 23, 2008

CONTOUR TEST STRIPS

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·July 8, 2011

NON AC-POWERED PATIENT LIFT

FDA Adverse Event
Malfunction ·UNKNOWN·Product code FSA·July 8, 2013

Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No

FDA Enforcement
Class II ·Ongoing·CooperSurgical, Inc.·December 25, 2024

BD PLASTIPAK¿ SYRINGES

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·March 28, 2023