15 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HI-EMT MAGSHAPE
FDA 510(k)
FDA Class 2
·Physical Medicine
Elite Orthopaedics
FDA UDI
Elite Orthopaedics, Inc.·00816591011017·Neoprene Hinged Knee Wrap, Medium
LEONE SPA
FDA UDI
LEONE SPA·08033707022831·CALIBRA BANDS 2ND MOLAR n.SUL 24
Intrigue
FDA UDI
LANCER ORTHODONTICS, INC.·00817573020065·INTRG WHISP-Z ROTH CUS0T +11A 018 UL
Cranial Electrotherapy Stimulator To Treat Depression
FDA Pre-Market Approval
FDA Class 3
·Flow FL-100
Spreader 13mm
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215067724·
uMR 570
FDA 510(k)
FDA Class 2
·Radiology
C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STARCLOSE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·November 12, 2008
ACCESS
FDA Adverse Event
Malfunction
·BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS·Product code FPA·August 31, 2011
ALARIS SE PUMP
FDA Adverse Event
Injury
·CAREFUSION CORPORATION·Product code FRN·July 10, 2013
MAZOR X SYSTEM
FDA Adverse Event
Malfunction
·MAZOR ROBOTICS LTD·Product code OLO·January 1, 2026
Positron Emission Tomography and Computed Tomography System, Model: uMI 550
FDA Enforcement
Class II
·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·October 19, 2022
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057
FDA Enforcement
Class II
·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·April 19, 2023
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only
FDA Enforcement
Class II
·Ongoing·UIH Technologies LLC·October 29, 2025