12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Bard® Fluoro-4™ Silicone Ureteral Stent
FDA UDI
C. R. Bard, Inc.·10801741011679·Bard® Fluoro-4™ Silicone Ureteral Stent with Hy...
PACS SOFTWARE SOLUTION 2003
FDA 510(k)
FDA Class 2
·Radiology
COMPASS CT, COMPASS CT PORT
FDA 510(k)
FDA Class 2
·Cardiovascular
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·September 22, 2020
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·February 27, 2026
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 22, 2025
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·September 27, 2023
AML 18.0 STD 6.3 5/8 STD 12/14
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·November 14, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011
BHR
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·July 18, 2013
cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.
FDA Recall
Terminated
·Roche Diagnostics Corporation·Product code JQP·December 27, 2016