16 results · 21ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

ALPHA-CORE DC

FDA 510(k)
FDA Class 2 ·Dental

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496070191·SOCKS FOR YOU BAMBOO CAREZZA, SIZE S, CORDA, GR...

Y2000 POCKET RESCUE

FDA 510(k)
FDA Class 2 ·Anesthesiology

TERASON MODEL 2000/BAS PORTABLE ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

WAVEWRITER ALPHA? 16

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 21, 2025

ISODUR PROSTHESIS HEAD 12/14 28MM M

FDA Adverse Event
Malfunction ·AESCULAP AG AND CO. KG·Product code LPH·January 16, 2015

HEARTSTART FRX

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 15, 2013

RESTORE RECHARGABLE NEUROSTIMULATOR

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·July 3, 2008

SUMMIT CEMENTED STEM SZ5 STD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·April 25, 2011

BD FACS 7-COLOR SETUP BEADS 25 TESTS

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·June 30, 2020

BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·May 8, 2025

BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·March 28, 2025

BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.

FDA Enforcement
Class II ·Terminated·Becton, Dickinson and Company, BD Biosciences·June 17, 2020

BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.

FDA Enforcement
Class II ·Terminated·Becton, Dickinson and Company, BD Biosciences·June 17, 2020

BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.

FDA Recall
Terminated ·Becton, Dickinson and Company, BD Biosciences·Product code PER·July 8, 2019

BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.

FDA Recall
Terminated ·Becton, Dickinson and Company, BD Biosciences·Product code PER·July 8, 2019