25 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SOMATOM DEFINITION FLASH
FDA 510(k)
FDA Class 2
·Radiology
AF541
FDA UDI
Respironics, Inc.·00606959024588·AF541 Mask with Entrainment Elbow, Leak 2, with...
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515234321·Semkin Bipolar Forceps, insulated, 1.5mm tips, 6"
UniTip Catheter
FDA UDI
Unisensor AG·07640172973875·
UniTip Catheter
FDA UDI
Unisensor AG·07640172973790·
FILMSAVER, NT VERSION 5.03
FDA 510(k)
FDA Class 2
·Radiology
TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE
FDA 510(k)
FDA Class 2
·Orthopedic
Widex
FDA UDI
Widex A/S·05706069818772·Widex UNIQUE U-FS (Winter silver ) 220, Telecoi...
Widex
FDA UDI
Widex A/S·05706069798630·Widex D-FA P (Winter silver ) Dream 220, Teleco...
Widex
FDA UDI
Widex A/S·05706069794168·Widex UNIQUE U-PA (Winter silver ) 220, RC coil
ACCELERATOR A3600
FDA Adverse Event
Malfunction
·INPECO SA·Product code JQP·December 20, 2024
TRANSSEPTAL NEEDLE, BRK 1, 71CM
FDA Adverse Event
Other
·ST. JUDE MEDICAL, AF DIVISION·Product code DRC·July 2, 2009
TENDRIL SDX
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code DTB·January 13, 2014
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·May 20, 2013
PENUMBRA SYSTEM SEPARATOR 032
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code NRY·June 9, 2011
Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
FDA Recall
Open, Classified
·GE Medical Systems, LLC·Product code ITX·November 10, 2022
ARTIS Q, Interventional Fluroscopic x-ray system
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 29, 2017
Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·December 28, 2022
AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·April 6, 2016
Artis Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·April 22, 2015