21 results
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19ms
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Sources: EU EUDAMED, US FDA
FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH)
FDA 510(k)
FDA Class 2
·Orthopedic
t:slim X2 Insulin Pump with Control-IQ+ Technology
FDA UDI
Tandem Diabetes Care, Inc.·00389152407210·Control-IQ+ 7.x, Replacement
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0140020·Driver Shaft, T30 No Taper, Final Cap Driver
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033559147·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033559178·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07310K0140020·Driver Shaft, T30 Final Cap, MIS
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033559123·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033559130·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033559154·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033559161·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033559116·
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0140120·Guide, Anti-Splay
POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE
FDA 510(k)
FDA Class 1
·General Hospital
PATIENT DOSE VERIFICATION SYSTEM, MODEL TN-RD-50
FDA 510(k)
FDA Class 2
·Radiology
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013
ACCENT DR RF
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 2011
BARD TRANSURETHRAL INJECTION SYSTEM
FDA Adverse Event
Malfunction
·C. R. BARD, INC.·Product code LNM·March 14, 2008
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
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 Recall
Open, Classified
·Tandem Diabetes Care, Inc.·Product code QFG·August 5, 2025
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012