12 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Persona® Personalized Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
TempoCem® Automix
FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG2121290·Temporary cement automix system. The temporary ...
NA
FDA UDI
Synthes GmbH·10886982152039·3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE REC...
VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN
FDA 510(k)
FDA Class 2
·Microbiology
ORTHO DEVELOPMENT ORION-I EMF SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SIMPLEXA COVID-19 DIRECT ASSAY
FDA Adverse Event
Malfunction
·DIASORIN MOLECULAR LLC·Product code QJR·November 2, 2021
MINILINK TRANSMITTER
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·October 29, 2014
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·July 8, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 8, 2013
UNKNOWN
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·December 2, 2015
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system 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.·August 5, 2015
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025