32 results · 32ms · Sources: EU EUDAMED, US FDA

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ANS SCS ACCESSORY KIT

FDA 510(k)
FDA Class 2 ·Neurology

PROTON VISION

FDA 510(k)
FDA Class 2 ·Radiology

TRI-FIX SPINAL FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

BD PHOENIX¿ SMIC-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 13, 2026

SIEMENS : ARTISTE MV

FDA Adverse Event
Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code IYE·July 30, 2010

EndoVive 3s Low Profile Balloon Kits Part Number: M00549390 (XMD P/N 70-0050-922) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

FDA Enforcement
Class II ·Terminated·Xeridiem Mediem Medical Devices Inc·March 2, 2016

TENSION FREE VAGINAL TAPE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code OTN·April 10, 2013

CAPSURE SP NOVUS

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 12, 2011

DURATA STS OPTIM

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008

BD PHOENIX¿ SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·October 16, 2024

BD PHOENIX¿ SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 1, 2024

G7 DUAL MOBILITY LINER 38MM C

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·July 12, 2022

BIOLOX DELTA OPTION HEAD, 28MM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code LZO·July 13, 2022

BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM LENGTH

FDA Adverse Event
Injury ·ZIMMER MANUFACTURING B.V.·Product code LPH·October 26, 2021

TPRLC 133 T1 PPS HO 15X150MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWL·October 25, 2021

REVISION SHELL LINER CEMENTED 0 DEGREE LINER FACE ANGLE 40 MM I.D.

FDA Adverse Event
Injury ·ZIMMER MANUFACTURING B.V.·Product code JDI·October 26, 2021

BONE SCR 6.5X20 SELF-TAP

FDA Adverse Event
Injury ·ZIMMER MANUFACTURING B.V.·Product code LPH·October 26, 2021

BD PHOENIX¿ SMIC-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025

BD PHOENIX¿ SMIC-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025

BONE SCREW SELF-TAPPING 6.5 MM DIA. 40 MM LENGTH

FDA Adverse Event
Injury ·ZIMMER MANUFACTURING B.V.·Product code LPH·October 26, 2021