14 results · 26ms · Sources: EU EUDAMED, US FDA

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PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)

FDA 510(k)
FDA Class 2 ·Dental

APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHOR

FDA 510(k)
FDA Class 2 ·Orthopedic

AVON PATELLAR COMPONENT

FDA 510(k)
FDA Class 2 ·Orthopedic

1823260-2017-01832

FDA Adverse Event
Malfunction ·August 28, 2017

BARRIGEL INJECTABLE GEL

FDA Adverse Event
Malfunction ·PALETTE LIFE SCIENCES·Product code OVB·June 24, 2024

COBAS 6000 E 601 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·December 5, 2017

VOYAGER NC CORONARY DILATATION CATHETER

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·October 30, 2008

RINGLOC ACETABULAR LINER 22MM HI WALL

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code LPH·August 23, 2011

ENDOPATH ETS 45

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GDW·July 8, 2013

COBAS 6000 CORE UNIT

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·October 12, 2017

1823260-2017-01311

FDA Adverse Event
Malfunction ·June 23, 2017

ELECSYS TSH ASSAY

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JLW·September 11, 2017

COBAS 6000 E 601 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·October 27, 2017

GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location.

FDA Enforcement
Class II ·Terminated·GE Healthcare, LLC·May 28, 2014