21 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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