16 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FDA 510(k)
FDA Class 2
·Radiology
ARTiC-L™ Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000085322·TRIAL 5250800 L 25 HT 8 DEG 0 FIXED
ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169791053·TRIAL 5250800 L 25 HT 8 DEG 0 FIXED
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813035818·Reamers With Silicone Stops 31MM #15
Bosma Enterprises
FDA UDI
Bosma Enterprises·00818634025487·Opportunity Pro Nitrile Exam Glove Extra Small ...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04059993397549·ELVAREX 1/THIGH HIGH/SLANT-OPEN TOE/DOTED SIL. ...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702783384·ELVAREX 2/KNEE HIGH/SLANT-OPEN TOE-ELEPHANTIASI...
TALOS®-C HA
FDA UDI
MEDITECH SPINE, LLC·B167522508000·
BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) // MACCONKEY II AGAR
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·December 29, 2023
Valved Safety Centesis Catheter
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS
FDA 510(k)
FDA Class 2
·General Hospital
Omnia Medical TiBrid™-L
FDA UDI
OMNIA MEDICAL, LLC·00843511106478·LATERAL INTERBODY, 22x45x8mm, 0°
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code FZP·December 2, 2008
DISPOSABLE HIP BONEC
FDA Adverse Event
Malfunction
·SMITH & NEPHEW MANSFIELD MANUFACTURING SITE·Product code HAB·September 16, 2011
ENDURANT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·July 29, 2013
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013