12 results
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38ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
Actera hip system
FDA UDI
Conformis, Inc.·00810933031404·Actera Stem Digital Template
ARTHREX FIBERWIRE, MODEL SPU-02NB-3800
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 6, 2023
SARA 3000
FDA Adverse Event
Injury
·ARJOHUNTLEIGH POLSKA SP. ZO.O.·Product code FSA·April 12, 2013
ZIMMER NATURAL HIP COLLARLESS POROUS STEM
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code KWY·April 26, 2011
AQUAMANTYS 2.3 BIPOLAR SEALER
FDA Adverse Event
Other
·SALIENT SURGICAL TECHNOLOGIES, INC.·Product code GEI·July 22, 2008
AVANTAGE INLAY S50 / 28
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·February 19, 2025
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 18, 2025
AVANTAGE 3P CUP PLASMA HA S50
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·November 14, 2024
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014