12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Medical Diode Laser (M2)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Oticon
FDA UDI
Sbo Hearing A/S·05714464028672·OTICON MORE 1 MINIRITE T C090 DEMO
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540177292·BIPOLAR FORCEPS
BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MEDICAL FLAT PANEL DISPLAY, ME315L
FDA 510(k)
FDA Class 2
·Radiology
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 17, 2008
UNICEL ® DXC600I SYNCHRON ® ACCESS ® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code MMI·September 1, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 16, 2013
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Recall
Open, Classified
·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Enforcement
Class II
·Ongoing·Abbott Point Of Care Inc.·September 24, 2025
ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025
ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025