10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
REMEL
FDA UDI
REMEL, INC.·00848838008146·MH Broth (5ml) 100/PK
RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND
FDA 510(k)
FDA Class 2
·Physical Medicine
MEDRAD MANUAL SYRINGE LOADER
FDA 510(k)
FDA Class 2
·Cardiovascular
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)·Product code MCX·April 16, 2013
HUDSON NEBULIZER ADAPTOR, STERILE, 033
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CAF·March 15, 2011
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·June 13, 2008
cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015