18 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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