27 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Safety Winged Blood Collection Sets
FDA 510(k)
FDA Class 2
·General Hospital
Comprehensive SRS
FDA UDI
Biomet Orthopedics, LLC·00880304714694·
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551112952·HALO, 1203-5 VEST LARGE, LAMBSWOOL LINER, 1211-...
SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
POWDER FREE POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES, NON-STERILE W/ PROTEIN CONTENT LABELING CLAIM 50 MCG OR LES
FDA 510(k)
FDA Class 1
·General Hospital
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·November 7, 2025
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·May 23, 2025
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·March 25, 2026
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·October 28, 2025
LYNX ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·December 12, 2025
LYNX ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·September 4, 2025
BD DISCARDIT SYRINGE S2
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·November 28, 2023
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75 CM NON US
FDA Adverse Event
Malfunction
·COTA RICA·Product code LTI·October 21, 2008
GORE HYBRID VASCULAR GRAFT
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DSY·August 3, 2011
CASHMERE 14 - CERECYTE MICROCOIL
FDA Adverse Event
Injury
·MICRUS ENDOVASCULAR, LLC·Product code HCG·July 8, 2013
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·April 15, 2026
BIPOLAR HANDLE CEV669BG DIA 5MM ERG
FDA Adverse Event
Malfunction
·INTEGRA MICROFRANCE S.A.S.·Product code GEI·December 20, 2023
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