12 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ETEST Fosfomycin (FO) (0.032-512 µg/mL)
FDA 510(k)
FDA Class 2
·Microbiology
LFIT V40 FEMORAL HEAD COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
TL-CERMIDE SKIN BARRIER EMULSION
FDA 510(k)
FDA Unclassified
·Unknown
KARDIAMOBILE
FDA Adverse Event
Malfunction
·ALIVECOR·Product code DPS·January 24, 2022
MENTOR
FDA Adverse Event
Malfunction
·MENTOR CORP.·Product code FWM·October 23, 2008
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·August 12, 2011
QUADRA ASSURA CRT-D, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 8, 2013
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·May 23, 2025
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·May 23, 2025
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·May 23, 2025
EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·October 7, 2015
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system 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.·August 5, 2015