10 results · 27ms · Sources: EU EUDAMED, US FDA

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VIMOVE

FDA 510(k)
FDA Class 2 ·Physical Medicine

Sasmar Vanilla

FDA UDI
Sasmar Pharmaceuticals SPRL·09337213008266·PERSONAL LUBRICANT

CLEARJET

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

FLUID FILLED TEETHERS

FDA 510(k)
FDA Class 2 ·Dental

OT VERIO SYNC METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 1, 2014

ALLEGRETTO WAVE

FDA Adverse Event
Injury ·WAVELIGHT GMBH·Product code LZS·May 23, 2013

ATTAIN ABILITY

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·June 16, 2011

TRANSMITTER MMT-7841ZW GST5G OUS

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code PQF·February 19, 2026

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions.

FDA Enforcement
Class III ·Terminated·Becton Dickinson & Co.·October 17, 2018