13 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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The InMode System with the Morpheus8 Applicators
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ELMED
FDA UDI
ELMED INCORPORATED·00842180173316·Intraarticular Tissue Grasper/Rongeur, 5" Stand...
ELMED
FDA UDI
ELMED INCORPORATED·00842180165908·Intraarticular Tissue Grasper / Rongeur, 7”Stan...
ELMED INCORPORATED
FDA UDI
ELMED INCORPORATED·00842180153325·INTRAARTICULAR TISSUE GRASPER/RONGEUR, 10" (25....
A9800 ANESTHESIA WORKSTATION
FDA 510(k)
FDA Class 2
·Anesthesiology
SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
OPTILITE® FREELITE® KAPPA FREE KIT
FDA Adverse Event
Injury
·THE BINDING SITE LIMITED·Product code DFH·March 30, 2026
OPTILITE® FREELITE® KAPPA FREE KIT
FDA Adverse Event
Injury
·THE BINDING SITE LIMITED·Product code DFH·March 31, 2026
CODEMASTER XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code LDD·October 14, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011
OSTYCUT DISPOSABLE BONE BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO. MEDIZINTECHNIK KG·Product code DWO·July 15, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022
BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020