8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PERITRON PERINEOMETER MODEL 9300V OR 9300A
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Polystar Selection EDITION HD
FDA UDI
Merz Dental GmbH·D7091983052·posteriors; shade B2; size M; upper jaw
ID-Cap System
FDA 510(k)
FDA Class 2
·General Hospital
EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA)
FDA 510(k)
FDA Class 2
·Immunology
LIGACLIP** ENDOSCOPIC CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·February 28, 2013
UNIVERSAL STEM 115X18MM FLUTED
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·February 4, 2011
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 6, 2014
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 10, 2013