22 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TGL FLEX REAGENT CARTRIDGE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743588·LEVAMED ANKLE SUPPORT SAND I
X-Guide
FDA UDI
XNAV TECHNOLOGIES LLC·00817421021237·TRACKER ARM ASSEMBLY, EDX, ANTERIOR UR
Medallion®
FDA UDI
Merit Medical Systems, Inc.·00884450543924·
SMI MEDICAL INSTRUMENTS GMBH & CO.KG
FDA registration
SMI MEDICAL INSTRUMENTS GMBH & CO.KG·24 products·🇩🇪 Germany
INSET
FDA Adverse Event
Injury
·UNOMEDICAL UM-D·Product code FPA·February 10, 2026
INSET II
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·November 24, 2025
INSET
FDA Adverse Event
Injury
·UNOMEDICAL UM-D·Product code FPA·February 10, 2026
DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER
FDA 510(k)
FDA Class 2
·Orthopedic
THINKINGNET
FDA 510(k)
FDA Class 2
·Radiology
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 2, 2025
CM ALVIM IMPLANT 5.0X13
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·March 16, 2018
MERIT CUSTOM KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code FMF·March 14, 2013
EZ-28 DELIVERY SYSTEM
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code MSS·March 3, 2011
QUICKSITE LV
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008
CHLORAPREP ONE STEP
FDA Adverse Event
Injury
·Product code KXG·August 23, 2021
DREAMSTATION AUTO CPAP
FDA Adverse Event
Death
·RESPIRONICS, INC.·Product code BZD·January 8, 2024
BD ANGIOCATH¿ IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·January 17, 2018
CHLORAPREP UNKNOWN
FDA Adverse Event
Injury
·CAREFUSION 213, LLC 0113·Product code OJU·August 25, 2021
Vertical Brake Hubs component of the Philips MX8000 Series Dual v. Exp. Computed Tomography System, Serial Numbers: 8008-8413, 80001-800022, Model #728130, 510 (k) #K010817. Product Usag: The MX 8000 series Dual v. Exp are Computed Tomography X-Ray system units intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code KPS·June 3, 2011