10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MEDICAL TECHNICAL PRODUCTS STANDARD ULTRASONIC HANDPIECE
FDA 510(k)
FDA Class 2
·Ophthalmic
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994128089·CASES 2940088 DL FLEX ARM TRAY
Reef TH
FDA UDI
Seaspine Orthopedics Corporation·10889981203191·Interbody, 9mm x 40mm x 8mm, 8 deg
Reef TA
FDA UDI
Seaspine Orthopedics Corporation·10889981195205·Interbody, 9mm x 40mm x 8mm, 8 deg
PHANTOM XL INSULATED DILATORS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
BIODEX ACT-O-KIT TSH-RIA-
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 2, 2013
INIFINITI VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·December 22, 2010
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 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