12 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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VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NA
FDA UDI
Medos International Sàrl·10886705003297·HYBRID FISHMOUTH DRILL GUIDE Durable drill guid...
EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL
FDA 510(k)
FDA Class 2
·Dental
AUTOGENESIS AUTOMATOR, MODEL M1000
FDA 510(k)
FDA Class 2
·Orthopedic
LUPINE DRILL GUIDE
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code HRX·January 15, 2008
LUPINE DRILL GUIDE
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code HRX·January 15, 2008
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN-BENNETT IRELAND·Product code CBK·October 22, 2008
PIN, BIO-TRANSFIX, 5MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code MAI·August 17, 2011
AVAULTA SOLO ANTERIOR SYNTHETIC SUPPORT SYSTEM
FDA Adverse Event
Injury
·BARD SHANNON LIMITED·Product code FTL·July 3, 2013
VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·January 8, 2020
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