15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ONCOBIONIC BIPOLAR ELECTRODE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014605593·MAQUET ALPHAMAXX 3" DELUXE
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450181089·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450600726·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450259283·
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 3, 2022
SCIMEDX PHASE II PR3 IGG ANTIBODY EIA
FDA 510(k)
FDA Class 2
·Immunology
BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO
FDA 510(k)
FDA Class 2
·Immunology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 5, 2024
CORE MICRO DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·April 26, 2013
ENGEN LABORATORY AUTOMATION SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·May 6, 2011
POLYFLUX LR CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIALYSATOREN GMBH·Product code MSF·July 24, 2008
HANDLE CEV102910R DIA 10MM ANG W/RATCHET [MXI/XOM]
FDA Adverse Event
Injury
·XOMED MICROFRANCE MFG·Product code GCJ·December 20, 2013
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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