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

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DIA-ROOT BIO MTA

FDA 510(k)
FDA Class 2 ·Dental

StarDental Instrument Solutions

FDA UDI
DENTALEZ, INC.·D7022001740·CLASSIQUE DIA INSTRUMENTS 110P

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114049·J-SHAPED CANNULA 25GA STRAIGHT (PK/10)

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306823329·Marina Nasal Osteotome, 3mm, 18cm

Initia Total Hip System

FDA UDI
KYOCERA MEDICAL CORPORATION·04580810058430·"MX LINER 36-72/74 Size:36-72/74 Type:Elevated ...

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306830945·Telescope, 4mm OD, 30 Degree, 17.5cm Length

DESS dental smart solutions

FDA UDI
TERRATS MEDICAL SL.·08435457200376·External Hex Universal

Initia Total Hip System

FDA UDI
KYOCERA CORPORATION·04547898306884·MX LINER 36-72/74

Liberty SI

FDA UDI
Spinal Simplicity, LLC·M9432001740000·Parallel Pin Placement Guide

O-arm O2 Imaging System

FDA 510(k)
FDA Class 2 ·Radiology

ACTION AF-1 WHEELCHAIR

FDA 510(k)
FDA Class 1 ·Physical Medicine

ANIMAS INSULIN CARTRIDGE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·December 18, 2015

ANIMAS INSULIN CARTRIDGE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·January 11, 2016

ANIMAS VIBE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·October 24, 2014

CAPSURE SENSE

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 10, 2011

UNK

FDA Adverse Event
Injury ·ETHICON INC.·Product code FTL·July 1, 2013

ANSPACH***REF SP-5000-00***Threaders, Arthroscopic Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems

FDA Enforcement
Class II ·Terminated·The Anspach Effort, Inc.·July 2, 2014

StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.

FDA Enforcement
Class II ·Terminated·Dental EZ Stardental Division·June 19, 2013

Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722227 (2) 722228

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024

Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

FDA Enforcement
Class II ·Terminated·Bayer Corp·June 11, 2014