15 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.

BodyTom 64

FDA 510(k)
FDA Class 2 ·Radiology

Cadence Science, Inc.

FDA registration
Cadence Science, Inc.·2 products·🇺🇸 United States

SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS

FDA 510(k)
FDA Class 2 ·Ophthalmic

TruAbutment DS, TruBase

FDA 510(k)
FDA Class 2 ·Dental

1213649-2000-00001

FDA Adverse Event
Other ·Product code DWO·June 16, 2000

1213649-2001-00002

FDA Adverse Event
Other ·Product code KNW·December 20, 2001

1213649-1999-00001

FDA Adverse Event
Other ·Product code KNW·February 26, 1999

BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·November 6, 2025

BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·November 19, 2025

OT VERIO METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 16, 2011

OMNIPOD INSULIN PUMP

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code LZG·September 26, 2014

ENDOTAK RELIANCE

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVY·July 9, 2013

COBAS® MPX - 96T

FDA Adverse Event
Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 26, 2025

HEARTMATE GOGEAR CONSOLIDATED BAG, LEFT

FDA Adverse Event
Malfunction ·THORATEC CORPORATION·Product code DSQ·September 3, 2025

Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019