11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING
FDA 510(k)
FDA Class 2
·Cardiovascular
artegral life
FDA UDI
Merz Dental GmbH·D7091993189·anteriors; shade B1; mould UBM
RFID Localization System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACTIPROTECT UC N95 RESPIRATOR
FDA 510(k)
FDA Class 2
·General Hospital
LONG NAIL KIT R2.0, TI, RIGHT GAMMA3 ?11X440MM X 1
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·November 20, 2012
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 7, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·August 8, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 7, 2011
GORE® DUALMESH® BIOMATERIAL
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code FTL·November 12, 2020
GORE® DUALMESH® BIOMATERIAL
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code FTL·November 12, 2020
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