19 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly
FDA 510(k)
FDA Class 2
·Cardiovascular
Elite Orthopaedics
FDA UDI
Elite Orthopaedics, Inc.·00816591011031·Neoprene Hinged Knee Wrap, X-Large
LEONE SPA
FDA UDI
LEONE SPA·08033707022879·CALIBRA BANDS 2ND MOLAR n.SUL 28
CPC BY SORING GMBH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RESURFX 1565NM LASER MODULE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Widex
FDA UDI
Widex A/S·05706069686845·Widex EVOKE E-IP (Clay brown ) 330, Right
Widex
FDA UDI
Widex A/S·05706069560190·Widex UNIQUE U-CIC (Clay brown ) 330, Left, RC ...
Widex
FDA UDI
Widex A/S·05706069655087·Widex UNIQUE U-IP (Clay brown ) 330, Right
Widex
FDA UDI
Widex A/S·05706069673333·Widex EVOKE E-CIC (Clay brown ) 330, Left, RC coil
Widex
FDA UDI
Widex A/S·05706069520231·Widex D-CIC (Clay brown ) Dream 330, Left, RC coil
Widex
FDA UDI
Widex A/S·05706069887112·WIDEX MOMENT M-IP (Clay brown ) 330, Right
Widex
FDA UDI
Widex A/S·05706069888980·WIDEX MOMENT M-CIC (Clay brown ) 330, Left
IMP,TSV,4.1MM,SBM,11.5
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·February 17, 2022
POLARCATH
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code DQY·November 12, 2008
CAPSURE SP
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 31, 2011
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 16, 2013
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