12 results · 38ms · Sources: EU EUDAMED, 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