65 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARC Intensive Care Information System (ARC System)
FDA 510(k)
FDA Class 2
·Cardiovascular
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220117150·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220117070·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220117000·
BBL™ CultureSwab™ Plus
FDA UDI
COPAN ITALIA SPA·38053326001858·CultureSwab Plus Amies w/o Charcoal Double
LINK Instruments - Chisel, bone curette, raspatory, rongeur
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575341344·Orthopaedic chisel - LINK SLED Prosthesis
OC-Auto
FDA UDI
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC·00816917027395·OC-Auto SENSOR io Personal Use Kit for VA Cinci...
OC-Auto
FDA UDI
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC·00816917021720·Personal Use Kit OC-Auto, for Cincinnati, OH
GC FUJI LINING LC PASTE PAK
FDA 510(k)
FDA Class 2
·Dental
CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
PharmGuard
FDA UDI
ICU MEDICAL, INC.·15019517225488·
PharmGuard
FDA UDI
ICU MEDICAL, INC.·15019517157888·
PharmGuard
FDA UDI
ICU MEDICAL, INC.·15019517177374·
AXIOS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 25, 2024
AXIOS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 3, 2024
AXIOS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024
AXIOS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·February 19, 2025
AXIOS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 21, 2024
AXIOS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 12, 2024
Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem Life Kit - V24/A17 Catalog #: 5840-2415 - LS Tandem Life Kit - V24/A15 Catalog #: 5740-2417 - TandemLife Kit - V24/A17 Catalog #: 5100-1422 - ProtekSolo Venous Dilator Set (14-22 Fr)
FDA Enforcement
Class II
·Terminated·Cardiac Assist, Inc·May 5, 2021