42 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
REPICCI II RESURFACING KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304008090·
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112892·CORNEAL TREPHINE BLADE7.0MM
COVERIS
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030CS1021540·Trial, 16mm x 20mm Lordotic 7°, 12mm
SPIRA®-A Integrated
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SAZ1021540·SPIRA®-A Integrated,Trial, 32x38mm, 20° Lordoti...
K.E.A.T.
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE
FDA 510(k)
FDA Class 2
·Radiology
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·January 6, 2006
QUICK CHECK ONE
FDA Adverse Event
DIAGNOSTIC SOLUTIONS, INC.·Product code CFR·January 21, 1997
SURESTEP
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code CGA·March 11, 1999
V200 / ESPRIT
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, LLC·Product code CBK·March 16, 2021
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·November 18, 2020
LIVONGO BLOOD GLUCOSE METER
FDA Adverse Event
Malfunction
·TELADOC HEALTH, INC.·Product code NBW·October 2, 2024
RESPIRONICS
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, LLC·Product code CBK·March 28, 2021
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 2, 2026
SURESTEP
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CGA·October 28, 1999
RESPIRONICS
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, LLC·Product code MNT·May 19, 2021
N-FORCE FC SCREW 4.0X45MM
FDA Adverse Event
Injury
·INNOVISION, INC.·Product code HWC·August 8, 2019
QUICK CHECK ONE
FDA Adverse Event
Malfunction
·DIAGNOSTIC SOLUTIONS, INC.·Product code CFR·April 24, 1997
RESPIRONICS
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, LLC·Product code CBK·May 20, 2021