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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MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EVONOS
FDA UDI
Gyrus ACMI, LLC·00821925028296·RICHARDS ALLIGATOR FORCEP-STRAIGHT 8 MM
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·AbsorbaSeal 5.6.7F Vascular Closure Device
POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE
FDA 510(k)
FDA Class 1
·General Hospital
PHILIPS MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS WITH PORTAL TECHNOLOGY AND M3185 OPT C41 WIRELESS BEDSIDE ADAPTR
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 20, 2025
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MRU·November 12, 2013
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·June 29, 2012
PINNACLE PELVIC FLOOR REPAIR KIT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code FTM·November 12, 2008
MAXIMO II DR
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code LWS·August 31, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 16, 2013
IMP, TSV, 4.7, 8, MTXF, MG, HA
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·August 24, 2021
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