13 results · 23ms · Sources: EU EUDAMED, 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