12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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U-Lite PRO
FDA 510(k)
FDA Class 2
·Radiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517630575·CoRoent Ant TLIF Ti, 13x12x28mm 15°
T:SLIM G5 SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OYC·October 25, 2019
OLYMPUS PREALBUMIN CALIBRATOR, ODR3029
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AEQUALIS REVERSED SHOULDER PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
AEQUALIS REVERSED BASE PLATE TA6V LONG PEG WITH HA
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·April 19, 2023
MITRAL SIZER HANDLE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DTI·November 5, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 2, 2011
GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·July 12, 2013
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
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
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 10, 2013