21 results · 25ms · Sources: EU EUDAMED, US FDA

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Powder Free Nitrile Examination Glove (Aqua Green)

FDA 510(k)
FDA Class 1 ·General Hospital

ELMED

FDA UDI
ELMED INCORPORATED·00842180149847·CLEANING BRUSH FOR 8 MM TROCAR SLEEVE, EACH

Scalpel

FDA UDI
Treace Medical Concepts, Inc.·00810111224543·GREATRELEASE™

METZENBAUM SCISSORS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896083639·METZENBAUM SCISSORS STRAIGHT BLADE POWER CUT GOLD

Ophthalmic Knife

FDA UDI
KATENA PRODUCTS, INC.·00841668113349·PHACO KNIFE 3.2MM ANGLED (BX/5)

POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

Disposable ECG Cable

FDA 510(k)
FDA Class 2 ·Cardiovascular

BIOSENSE WEBSTER LASSO 7FR 20MM DEFLECTABLE CIRCULAR CATHETER

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER, INC.·Product code DRF·August 22, 2007

T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·July 16, 2020

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

INTERSTIM II

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·October 24, 2014

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 1, 2013

SCREW-IN TEMPORARY LEAD

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code LDF·October 6, 2017

ATTAIN CS

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code LWP·April 14, 2021

UNKNOWN ANGIOGUARD

FDA Adverse Event
Injury ·CORDIS CORPORATION·Product code NTE·December 28, 2017

UNKNOWN ANGIOGUARD

FDA Adverse Event
Injury ·CORDIS CORPORATION·Product code NTE·December 26, 2017

SYNVISC (HYLAN G-F 20) INJECTION

FDA Adverse Event
Other ·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·April 25, 2013

PLATE, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code HRS·March 12, 2015

VIDAS® ANALYZER

FDA Adverse Event
Malfunction ·BIOMERIEUX ITALIA S.P.A.·Product code DEW·August 6, 2019

St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 11, 2018