12 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VitalDetect
FDA 510(k)
FDA Class 2
·General Hospital
BD BBL™ Sensi-Disc™ Azlocillin - 75 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902316252·BD BBL™ Sensi-Disc™ Azlocillin - 75 µg
Meridian
FDA UDI
Seaspine Orthopedics Corporation·10889981247331·No-Profile Interbody, 39mm x 30mm x 16mm, 25 Deg
POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLORED
FDA 510(k)
FDA Class 1
·General Hospital
ANYSCAN-S SPECT IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·November 13, 2008
6 SHOOTER SAEED MULTI-BAND LIGATOR
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC.·Product code MND·August 15, 2011
UNKNOWN SOFRADIM PRODUCT
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·July 12, 2013
KIDS OXYGENATOR D101
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·April 4, 2025
VITROS Chemistry Products GLU DT Slides GEN 56, REF (Catalog #) 153 2316, 25 slides per box. VITROS Chemistry Products GLU DT Slides quantitatively measure glucose (GLU) concentration in serum and plasma. Ortho-Clinical Diagnostics, a Johnson & Johnson company. Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626. .
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code CGA·September 27, 2006
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022