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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JAZZ Solo sensor
FDA 510(k)
FDA Class 2
·Dental
BD BBL¿ ENRICHED THIOGLYCOLLATE MEDIUM
FDA Adverse Event
Injury
·BECTON DICKINSON & CO. (SPARKS)·Product code JSG·January 30, 2025
ACTICHROME HEPARIN (ANTI-FIIA)
FDA 510(k)
FDA Class 2
·Hematology
HAMILTON-C3
FDA 510(k)
FDA Class 2
·Anesthesiology
BD POSIFLUSH¿ SP
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code NGT·May 12, 2020
5 ML BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9%
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code NGT·May 4, 2020
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011
ACUSON
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SOLUTIONS USA INC.·Product code IYN·September 26, 2014
PATCH
FDA Adverse Event
Injury
·HISTORICAL CPI ST. PAUL·Product code NHW·July 9, 2013
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019
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