30 results · 31ms · Sources: EU EUDAMED, US FDA

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SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL]

FDA 510(k)
FDA Class 2 ·Cardiovascular

Neo-Tee T-Piece Resuscitator Circuit

FDA UDI
MERCURY ENTERPRISES, INC.·10641043509166·

UFI GEL HARD C

FDA 510(k)
FDA Class 2 ·Dental

PTW DOSIMETRY DIODE, T60008

FDA 510(k)
FDA Class 2 ·Radiology

BD PHOENIX¿ SMIC-101

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

EndoVive 3s Low Profile Balloon Kits Part Number: M00548580 (XMD P/N 70-0050-916) 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

AEQ REV II GLENOID BASEPLATE DIA 25MM

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code PHX·July 1, 2025

AEQUALIS REVERSED BASE PLATE TA6V LONG PEG WITH HA

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·March 13, 2025

AEQ REV GLENOID BASEPLATE 29MM

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·March 6, 2025

ADAPTA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·April 10, 2013

ENDOPATH** XCEL* TROCAR

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·April 12, 2011

RIATA ACTIVE FIXATION LEAD

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

PRISMA SET

FDA Adverse Event
Malfunction ·GAMBRO INDUSTRIES·Product code FJK·November 20, 2006

PRISMA SET

FDA Adverse Event
Malfunction ·GAMBRO INDUSTRIES·Product code KDI·November 9, 2006

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

BD PHOENIX¿ SMIC-101

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

AEQUALIS REVERSED MULTIDIRECTIONAL GLENOID PLATE HA

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·March 25, 2024