31 results
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21ms
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Sources: EU EUDAMED, US FDA
GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BONE HOLDING FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896051355·BONE HOLDING FORCEPS WITH RATCHET/K-WIRE GUIDE ...
GEN4 Direct Access
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828107105·GEN4 Direct Access
GEN4 Direct Access
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828132404·GEN4 Direct Access
NexxZr™ / W-98-35-UT-B300-ML
FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271139061·
ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON, ECHOTECH EASYSTRESS
FDA 510(k)
FDA Class 2
·Radiology
21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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·December 17, 2024
AXIOS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·February 20, 2025
AXIOS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024
FRONTRUNNER XP CTO CATHETER SYSTEM
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code DQY·May 9, 2013
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·September 19, 2014
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·May 25, 2011
VAPR VUE WIRELESS FOOTSWITCH
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code GEI·November 17, 2020
AXIOS?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024
AXIOS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 27, 2024
VAPR VUE WIRELESS FOOTSWITCH
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code GEI·March 3, 2022
Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies Model Numbers: Sensis Vibe Hemo 11007641 Sensis Vibe Combo 11007642 Sensis 10764561 Postprocessing Workstation 6648161 SIS Server 6648153
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 10, 2021