22 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
N/A
FDA UDI
GEORGE TIEMANN & CO.·B58280140730·CURETTE
t:slim X2 Insulin Pump with Control-IQ+ Technology
FDA UDI
Tandem Diabetes Care, Inc.·00389152407319·Control-IQ+ 7.x, Refurbished
16PW - SEC - Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588140735·16PW - SEC - Poly White
IRONMAN
FDA UDI
FGX INTERNATIONAL INC.·00193033559215·
IRONMAN
FDA UDI
FGX INTERNATIONAL INC.·00193033559192·
IRONMAN
FDA UDI
FGX INTERNATIONAL INC.·00193033559222·
IRONMAN
FDA UDI
FGX INTERNATIONAL INC.·00193033559185·
IRONMAN
FDA UDI
FGX INTERNATIONAL INC.·00193033559208·
IRONMAN
FDA UDI
FGX INTERNATIONAL INC.·00193033559239·
IRONMAN
FDA UDI
FGX INTERNATIONAL INC.·00193033559246·
SPARROWHAWK DISPOSABLE
FDA 510(k)
FDA Class 2
·Cardiovascular
SPLINE DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
ALLURA XPER FD10
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code IZI·October 16, 2025
PISCES - QUAD
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO, VILLALBA·Product code GZB·May 31, 2007
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013
TENDRIL STS
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011
BARD TRANSURETHRAL INJECTION SYSTEM
FDA Adverse Event
Malfunction
·C. R. BARD, INC.·Product code LNM·March 14, 2008
HEARTMATE 3 LVAS IMPLANT KIT
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·June 22, 2022
t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when using Dexcom G7 sensor; Tandem Mobi insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014801, 1014811, 1014813, and User Guide when using Dexcom G7 sensor
FDA Enforcement
Class II
·Ongoing·Tandem Diabetes Care, Inc.·October 29, 2025