19 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER
FDA 510(k)
FDA Class 2
·Anesthesiology
NA
FDA UDI
STERIS CORPORATION·10724995152373·The Vis-U-All High Temperature Heat Seal Steril...
PROXIMATE*II DISPOSABLE SKIN STAPLER
FDA 510(k)
FDA Class 2
·General Hospital
Corin Optimized Positioning System (OPS) Plan
FDA 510(k)
FDA Class 2
·Radiology
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Malfunction
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 11, 2019
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Injury
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 2, 2019
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Malfunction
·OPTIMIZED ORTHO PTY LTD·Product code LZO·February 12, 2020
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Malfunction
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 11, 2019
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Malfunction
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 10, 2019
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Injury
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 10, 2019
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Injury
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 11, 2019
UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·October 26, 2010
INRATIO2
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·December 18, 2012
2.8MM THREADED GUIDE WIRE
FDA Adverse Event
Malfunction
·SYNTHES ELMIRA·Product code HWC·November 2, 2013
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·February 13, 2020
Vis-U-All High Temp 3"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
FDA Enforcement
Class II
·Terminated·Steris Corporation·March 7, 2018
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Injury
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 10, 2019
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Injury
·CORIN AUSTRALIA PTY LTD·Product code LZO·December 9, 2019
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Malfunction
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 2, 2019