566 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AC Cream - Conductive paste
FDA 510(k)
FDA Class 2
·Neurology
NA
FDA UDI
Synthes GmbH·10886982152589·3.5MM CONICAL SCREW SLF-TPNG FULLY THREADED 70MM
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113349·PHACO KNIFE 3.2MM ANGLED (BX/5)
Distal Ulna Plate
FDA UDI
I.T.S. GmbH·09120047296509·Distal Ulna Plate, 6-Hole, Left
WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SMARTTOOLS KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
INFUSO.R. PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·October 29, 2008
AMPLATZER SEPTAL OCCLUDER
FDA Adverse Event
Injury
·AGA MEDICAL CORPORATION·Product code MLV·August 15, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 9, 2013
I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers. 1. I.T.S. DUL (Distal Ulna Locking) System, Distal Ulna Plate; Article Numbers: 21232-3, 21232-4, 21232-6, 21233-3, 21233-4, 21233-6, 21234-4, 21235-4. 2. I.T.S. UOL (Ulna Osteotomy Locking) System, Ulna Osteotomy Plate; Article Numbers: 21231-6. 3. UOL (Ulna Osteotomy Locking) System, Cancellous Screw, Locking; Article Numbers: 37302-18, 37302-20.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026
INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code PKL·December 19, 2022
INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code PKL·June 9, 2022
INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code PKL·January 2, 2025
INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code PKL·June 30, 2022
INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code PKL·July 17, 2024
INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code PKL·September 12, 2024
INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code PKL·May 26, 2022
INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
FDA Adverse Event
Injury
·WILSON-COOK MEDICAL INC·Product code PKL·June 9, 2022
INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code PKL·April 4, 2022
INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code PKL·September 7, 2023