13 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Radialis PET Camera
FDA 510(k)
FDA Class 2
·Radiology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613018009·K-Wire, Single Ended, Trocar Point, Diameter Si...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017781·K-Wire, Double Ended, Trocar Point, Diameter Si...
NA
FDA UDI
Synthes GmbH·10886982153630·4.5MM CORTEX SCREW 62MM
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551114017·HALO, CTLSO VEST SMALL, ACRYLIC LINER, 1201-1 S...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017798·K-Wire, Double Ended, Trocar Point, Diameter 0....
SIMPLICITY EASY ACCESS INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
QDC-PRO, AND NOX-RIP
FDA 510(k)
FDA Class 2
·Anesthesiology
SUPER WERNET'S POWDER
FDA Adverse Event
Other
·GLAXOSMITHKLINE·Product code KOL·July 20, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 30, 2014
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 9, 2013
UROSKOP Omnia Max. Model Number: 10762473
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·June 25, 2025
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