18 results · 27ms · 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.

NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

PINNACLE®

FDA UDI
B. BRAUN MEDICAL INC.·04046955772834·DCB PINNACLE 3000ML SINGLE PACK

InFill Lordotic TLIF

FDA UDI
PINNACLE SPINE GROUP, LLC·00814729025110·

CLEARMEDICAL/HUNTLEIGH FOOT GARMENTS; MODELS FG200/LRG (LARGE), FG200/STD (STANDARD), FG100/SM (SMALL), FG100-R (REGULAR

FDA 510(k)
FDA Class 2 ·Cardiovascular

NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE

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

MAINFRAME 8253001 NIM RESPONSE 3.0

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·February 24, 2014

EMG TUBE 8229737 3PK NIM TRIVANTAGE 7MM

FDA Adverse Event
Injury ·MEDTRONIC XOMED, INC.·Product code ETN·November 12, 2014

RESERVOIR 3ML

FDA Adverse Event
Malfunction ·Product code FRN·May 14, 2013

OCTRODE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 10, 2014

ALTRX NEUT 28IDX48OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 19, 2011

NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·July 19, 2016

NIM® 3.0 MAINFRAME

FDA Adverse Event
Injury ·MEDTRONIC XOMED INC.·Product code ETN·January 14, 2015

NIM® 3.0 MAINFRAME

FDA Adverse Event
Injury ·MEDTRONIC XOMED INC.·Product code ETN·August 15, 2016

DEKA SMARTXIDE² TRIO

FDA Adverse Event
Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·October 31, 2023

NIM® PROBE

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·March 23, 2018

NIM® PROBE

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·May 11, 2015

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Model Number L131, ESSENTIO DR EL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025