29 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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