17 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OPERATING ROOM TOWEL, STERILE, COLORS BLUE OR WHITE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Endo-Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964015838·Endo Carry-on Procedur Kit contains all of the ...
TruForm
FDA UDI
Rmo, Inc.·00885797099709·MX MLR BDS R/L SE ASIA ASST100
BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·August 20, 2019
MINIMED MIO
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·February 4, 2025
BD INTEGRA¿ 3 ML RETRACTING SAFETY SYRINGE WITH 23 G X 1 IN.
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 13, 2022
MINIMED MIO
FDA Adverse Event
Injury
·UNOMEDICAL UM-D·Product code FPA·February 9, 2025
AUDIOSCREENER OAE + ABR
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
WEHRS INCUS-STAPES
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
LINOX TD 65/16
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVY·March 13, 2013
TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM
FDA Adverse Event
TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code GCJ·February 21, 2011
ALENTI WITH SCALE
FDA Adverse Event
Malfunction
·ARJO HOSPITAL EQUIPMENT AB·Product code FSA·February 25, 2008
SURETEK?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code MHY·September 9, 2025
BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically designed for IV connection to an Interlink¿ injection site. It is screwed down over the Interlink¿ injection site and a blunt plastic cannula inside the housing enters the Interlink¿ injection site to provide a pathway for IV fluid administration.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·January 22, 2014
PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024
Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·November 2, 2016