13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
XLIF
FDA UDI
Nuvasive, Inc.·00887517415868·MaXcess 4 Retractor Level
Guided Surgery
FDA UDI
BICON, LLC·00813110026309·4.0mm Guided Surgery Rings
System, Imaging, Pulsed Doppler, Ultrasonic
FDA Pre-Market Approval
FDA Class 2
·ULTRAMARK 9 HIGH DEFINITION IMAGING UULTRASOUND SYSTEM
Pharmaceutical Innovations
FDA UDI
PHARMACEUTICAL INNOVATIONS INC·00300369400054·Pre-Tac TENS Conductive Skin Preparation:5 ml b...
PROFILE 2000/3000 LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ALMA DIODE TABLETOP LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
System, Imaging, Pulsed Doppler, Ultrasonic
FDA Pre-Market Approval
FDA Class 2
·HDI 3000 ULTRASOUND SYSTEM
System, Imaging, Pulsed Doppler, Ultrasonic
FDA Pre-Market Approval
FDA Class 2
·HDI 3000 ULTRASOUND SYSTEM WITH L12-5 SCANHEAD
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·February 1, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·December 28, 2010
OT VERIO IQ 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