14 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SARNS CARDIOPLEGIA CANNULAE (VAR. TYPES
FDA 510(k)
FDA Class 2
·Cardiovascular
STRADIS HEALTHCARE
FDA UDI
STRADIS MEDICAL, LLC·M7526822210·
LEONE SPA
FDA UDI
LEONE SPA·08033707066439·LIGAT SLIDE LOW FRICTION ICE MEDIUM
Epimed
FDA UDI
EPIMED INTERNATIONAL, INC·00818788022516·R-F™ Cannula B-Bevel 22g x 10cm w/ 10mm Active Tip
Invenio
FDA UDI
Gri-Alleset, Inc.·00840365903338·Vein Hawaii Vein Pack
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113492·PS-C Insert, Size 2 x 10mm
NA
FDA Adverse Event
Malfunction
·STERIS CORPORATION·Product code FTA·November 2, 2021
MULTIFUNCTIONAL ELECTRODE MODELS 9640, 9650
FDA 510(k)
FDA Class 3
·Cardiovascular
NEWFIX EXTERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HS ACE 14 CM SCISSOR HANDLE
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·December 3, 2007
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·November 7, 2012
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 20, 2014
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015