10 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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Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray
FDA 510(k)
FDA Class 2
·General Hospital
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331168536·mayo-hegar needle holder, serrated jaws, 8" (20...
SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT
FDA 510(k)
FDA Class 2
·Anesthesiology
TRANSTEK
FDA 510(k)
FDA Class 2
·Cardiovascular
QUADROX ID
FDA Adverse Event
Injury
·DATASCOPE CORP.·Product code DTZ·October 24, 2014
SMARTSITE EXTENSION SET
FDA Adverse Event
Injury
·CAREFUSION CORP.·Product code FPA·August 3, 2011
INSIGNIA
FDA Adverse Event
Malfunction
·GUIDANT CLONMEL IRELAND·Product code LWP·July 9, 2013
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
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 22, 2026
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023