11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Sample preservation solution
FDA 510(k)
FDA Class 2
·Microbiology
Bernafon
FDA UDI
Bernafon AG·05711584114872·CZ9 MNR T R, 2.4G NFM MAC CORAL 9 GPL
HD-IVUS ULTRASOUND IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 25, 2014
CAREASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM PLUVIGNER·Product code FNL·July 12, 2011
2520274-2013-04115
FDA Adverse Event
Injury
·SYNTHES USA·Product code JEY·July 9, 2013
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
FDA Recall
Open, Classified
·FUJIFILM Healthcare Americas Corporation·Product code OTE·June 11, 2025
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025
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
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023