26 results · 22ms · Sources: EU EUDAMED, US FDA

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ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MEDIANT

FDA UDI
INTELLIGENT IMPLANT SYSTEMS, LLC·00814033021273·Mediant 2.0 mm Drill Guide

BOSS Instruments

FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515016569·Mayo Hegar N.H., 9"

Cervical Interbody 13mm x 12mm x 9mm Packaging

FDA UDI
XENCO MEDICAL LLC·B064XM11213091·Cervical Interbody 13mm x 12mm x 9mm

MDT Diamond Coated Dental Burs

FDA UDI
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·17291046340155·Rotary diamond instrument for dental application

MDT Diamond Coated Dental Burs

FDA UDI
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·17291046364670·Rotary diamond instrument for dental application

MDT Diamond Coated Dental Burs

FDA UDI
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·17291046340162·Rotary diamond instrument for dental application

MDT Diamond Coated Dental Burs

FDA UDI
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·17291046364663·Rotary diamond instrument for dental application

EXELINT ALUMINUM HUB BLUNT NEEDLES

FDA 510(k)
FDA Class 2 ·General Hospital

DIGITAL RADIOGRAPHY

FDA 510(k)
FDA Class 2 ·Radiology

ALARIS SYSTEM

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·March 26, 2022

TENDRIL DX

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC. CRMD·Product code DTB·January 13, 2014

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013

ACCU-CHEK ® AVIVA TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 13, 2011

BRYAN® CERVICAL DISC SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code MJO·May 29, 2012

INSPIRE 8F DUAL

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTN·January 9, 2026

INSPIRE 6 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES

FDA Adverse Event
SORIN GROUP ITALIA S.R.L.·Product code DTZ·December 7, 2016

Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2)

FDA Recall
Terminated ·General Electric Med Systems LLC·Product code LLZ·October 8, 2004

Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model Number: 10848282

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 10, 2019

ARTIS Q biplane with Material 10848282- - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee includes cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee can also support the acquisition of position triggered imaging for spatial data synthesis.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·November 21, 2018