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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STIMPOD NMS450 Nerve Stimulator
FDA 510(k)
FDA Class 2
·Anesthesiology
Vitique
FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG2130491·Water soluble glycerin-free Try-in-paste for Ve...
36M - PacifiCorp - Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588130491·36M - PacifiCorp - Metal
NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE
FDA 510(k)
FDA Class 2
·Dental
SOCKET GRAFT
FDA 510(k)
FDA Class 2
·Dental
VOYAGER NC CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·August 16, 2011
CENTURION VISION SYSTEM
FDA Adverse Event
Injury
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·October 24, 2014
INGENIO
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·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
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023