12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES
FDA 510(k)
FDA Class 2
·Orthopedic
SURGICAL SYSTEM WITH CRYOGUIDE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ASAHI REXEED-LX SERIES DIALYZER
FDA Adverse Event
Injury
·ASAHI KASEI MEDICAL CO., LTD.·Product code KDI·May 4, 2012
PLATE,FIXATION,BONE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HRS·May 9, 2014
BD BBL¿ PLATE COLUMBIA III AGAR 5% SB 90MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code KZI·May 16, 2023
SHILEY
FDA Adverse Event
Malfunction
·COVIDIEN·Product code JOH·April 23, 2013
MELODY TRANSCATHER PULMONARY VALVE
FDA Adverse Event
Malfunction
·THE HEART VALVE DIV. MEDTRONIC CARDIOVASCULAR SURG·Product code NPV·April 27, 2011
TERUMO CENTRIFUGAL SYSTEM
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code KFM·July 23, 2008
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
FDA Enforcement
Class II
·Terminated·Care Essentials Pty., Ltd.·February 12, 2020
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