23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD; ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743663·ACHIMED ACHILLES SUPP SILVER III
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·10843717103124·Midway Select Disposable Diamonds 856-016SC, Pk...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690129837·PS Insert, Size 3 x 13mm
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0103130·Shaver, Closed, 13mm
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345024083·Paddle Shaver, 13mm
TEARAWAY INTRODUCER SHEATH
FDA 510(k)
FDA Class 2
·Cardiovascular
COMPLEXED PSA MICROTITER ELISA
FDA 510(k)
FDA Class 2
·Immunology
BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·September 4, 2025
BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 23, 2026
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·March 25, 2013
PUMP IN STYLE ADVANCED, BACK PACK
FDA Adverse Event
Other
·MEDELA, INC.·Product code HGX·March 11, 2011
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·March 26, 2008
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 22, 2024
BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·January 9, 2024
BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 31, 2024
BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·December 26, 2023
BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·February 21, 2024
BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·October 7, 2024