10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Veinoflow SCD (Model: LBTK-M-I 5006)
FDA 510(k)
FDA Class 2
·Cardiovascular
MOLECULAR ADSORBENT RECIRCULATING(MARS)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 30, 2014
COLLEAGUE PRE-P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011
AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - ANTERIOR
FDA Adverse Event
Injury
·BARD SHANNON LIMITED·Product code FTL·July 2, 2013
CustMbite, Model Number CBT-SRS-UL
FDA Enforcement
Class II
·Ongoing·Dental Choice Holding Llc·August 10, 2022
LIFE SCOPE G9
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·June 13, 2024
LIFE SCOPE G9
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·October 27, 2023
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017