12 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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QUIXIE NEBULIZER
FDA 510(k)
FDA Class 2
·Anesthesiology
9340 2WAY BALOON VALVE
FDA UDI
HANS RUDOLPH, INC.·00874750009060·9340A 2WAY SHUT-OFF 22MM OD
MODIFICATION TO: VECTORVISION FRAMELESS BIOPSY SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
MAXFIRE MARXMEN MENISCAL REPAIR DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
SUBCUTANEOUS, UNIPOLAR LEAD
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code LWS·February 4, 2020
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 14, 2013
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·September 24, 2014
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·May 26, 2011
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
FDA Enforcement
Class II
·Ongoing·Abbott Medical·January 1, 2025