28 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.

BluEX Lumbar Expandable Cage System

FDA 510(k)
FDA Class 2 ·Orthopedic

DBX STRIP

FDA 510(k)
FDA Class 2 ·Orthopedic

Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating; Flexor Check-Flo Introducer Balkin Up and Over Contralateral Design; Flexor Up and Over Balkin Contralateral Introducer; Flexor Check-Flo Introducer, Raabe Modification; Flexor Check-Flo Performer Introducer

FDA 510(k)
FDA Class 2 ·Cardiovascular

FLEXOR RTPS GUIDING SHEATH

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·February 27, 2020

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014

RIATA ACTIVE FIXATION

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011

GYNECARE TVT OBURATOR SYSTEM

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTN·July 23, 2013

SYNCHROMED II

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·March 12, 2015

FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·September 29, 2020

ARCOS 17X150MM SPL TPR DIST

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWA·June 12, 2024

ARCOS CON SZ C STD 60MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWA·June 12, 2024

FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·March 3, 2020

THAL-QUICK CHEST TUBE SET

FDA Adverse Event
Malfunction ·COOK INC·Product code GBX·January 7, 2020

FLEXOR ANSEL GUIDING SHEATH

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·March 3, 2020

UNKNOWN

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·January 10, 2022

FLEXOR ANSEL GUIDING SHEATH

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·October 22, 2019

FLEXOR RAABE GUIDING SHEATH

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·December 11, 2019

FLEXOR ANSEL GUIDING SHEATH

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·October 22, 2019

FLEXOR RAABE GUIDING SHEATH

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·November 27, 2019

FLEXOR ANSEL GUIDING SHEATH

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·November 18, 2019