15 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Riptide Aspiration System (Riptide Large Bore Aspiration System)
FDA 510(k)
FDA Class 2
·Cardiovascular
OsteoMed
FDA UDI
OSTEOMED LLC·00845694053709·SmartFlex SPRING NC - 8.5N
CADI SMARTSENSE VITAL SIGNS AND WIRELESS TEMPERATURE MONITORI NG SYSTEM, MODEL S1
FDA 510(k)
FDA Class 2
·General Hospital
TOSHIBA 1.5T EXTRA LARGE KNEE COIL
FDA 510(k)
FDA Class 2
·Radiology
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 16, 2021
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/17MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 8, 2022
CONNECSCR F/DHS/DCS-WRENCH NO. 338.300
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HWB·June 21, 2013
ARCHITECT CA 125 II
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code LTK·October 3, 2008
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE ? SHERBROOKE·Product code FPA·July 28, 2011
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·September 14, 2021
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·September 14, 2021
Niobe ES System, Models 001-006000-1 and 001-006100-1
FDA Enforcement
Class II
·Terminated·Stereotaxis Inc·November 18, 2020
Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Model Number: 7200.01F2
FDA Enforcement
Class II
·Ongoing·Getinge Usa Sales Inc·October 11, 2023
Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020