9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SUPERGEL/SUPPRESSED DUST
FDA 510(k)
FDA Class 2
·Dental
AXSOS
FDA UDI
Stryker GmbH·07613327089264·Plate Tray with lid Double Lax
Peerless Buccal Tube
FDA UDI
ORMCO CORPORATION·00889989022810·PRLS TPL 10 UFM GING. 0X18 0X18X45 RT
ANGIODYNAMICS, INC. MORE-FLOW HEMODIALYSIS CATHETER AND PROCEDURE KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS MALE ADAPTER, MEDSOURCE IV EXTENSION SET
FDA 510(k)
FDA Class 2
·General Hospital
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code NKB·February 3, 2013
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Malfunction
·CORDIS LLC (PR)·Product code NIQ·December 29, 2010
POLYLOOP
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code MND·July 7, 2014
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020