14 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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HipCheck
FDA 510(k)
FDA Class 2
·Radiology
LessRay
FDA UDI
Nuvasive, Inc.·00887517994820·LessRay Image Enhancement Sys Computer
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036034900·
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776297282·Sealing Cap Pkg 10
SacroFuse
FDA UDI
SPINEFRONTIER, INC.·00190361036050·SCREW, SOLID WALL, CANNULATED, Ø8MM X 45MM, SAC...
Awl Guide
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215067755·
MUTARS Cemented Femoral Stems
FDA 510(k)
FDA Class 2
·Orthopedic
OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)
FDA 510(k)
FDA Class 1
·Clinical Toxicology
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 17, 2008
CONCERTO II CRT-D
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code NIK·August 31, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 16, 2013
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
BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers
FDA Enforcement
Class II
·Ongoing·Civco Medical Instruments Co. Inc.·June 11, 2025
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