19 results · 24ms · Sources: EU EUDAMED, US FDA

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STERI-DENT, STERI-SURE

FDA 510(k)
FDA Class 2 ·General Hospital

JOBST SensiFoot

FDA UDI
BSN MEDICAL, INC.·00035664108670·SENSIFOOT 8-15 MM HG KNEE HIGH MEDIUM BLACK 1 E...

Leva® Anterior Interbody System

FDA UDI
Spine Wave, Inc.·10840642108224·Plate, 26 mm/30 mm (W) x 17 mm (H)

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306803727·Goulet-Simpson Retractor, Small 1"

VICOR PD2I ANALYZER

FDA 510(k)
FDA Class 2 ·Cardiovascular

KILEJIAN CIRCUMCISOR

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 7, 2025

EON MINI

FDA Adverse Event
Injury ·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 9, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 23, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 2, 2011

PEDIASAT

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES PR·Product code DRE·December 10, 2025

EDWARDS OXIMETRY CENTRAL VENOUS CATHETER

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code DXG·January 7, 2025

EDWARDS OXIMETRY CENTRAL VENOUS CATHETER

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES PR·Product code DQE·March 27, 2025

EDWARDS OXIMETRY CENTRAL VENOUS CATHETER

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code DXG·January 7, 2025

VERSE POLY DRIVER SHAFT NAV

FDA Adverse Event
Malfunction ·DEPUY SPINE INC·Product code OLO·April 29, 2022

Video Duodenoscope

FDA Enforcement
Class II ·Terminated·Pentax Medical Company·June 8, 2016

Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

Model Number L131, ESSENTIO DR EL MRI Pacemaker

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