21 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Unity Total Knee System
FDA UDI
CORIN LTD·05056139249051·UNITY KNEE™ PS-C INSERT - Size 7T-8F x 9mm
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00812564031198·Basic Pack, Major
Milling Drum Extra Extra Extra Fine
FDA UDI
Spierings Orthopaedics B.V.·08720254007861·
7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETIT
FDA 510(k)
FDA Class 2
·Anesthesiology
TEMPOCEM
FDA 510(k)
FDA Class 1
·Dental
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·March 31, 2025
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·June 11, 2025
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·May 30, 2025
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·March 5, 2025
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·June 5, 2025
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·January 28, 2025
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·July 28, 2025
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 20, 2013
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code MMI·June 10, 2011
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC SWISS MANUFACTURING FACILITY·Product code EZW·August 15, 2008
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·September 30, 2025
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·May 12, 2025
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·January 10, 2025
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015