9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PERCUTANEOUS SHEATH INTRODUCER KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
The Orthodontic Store
FDA UDI
Young Innovations, Inc.·00843471162576·Nickel Free Micro Nonconvertible Bondable Bucca...
BENACEL, MODELS C-001, C-002 AND C-005
FDA 510(k)
FDA Unclassified
·Unknown
COMPUTER, CARDIAC OUTPUT (#SP1425)
FDA 510(k)
FDA Class 2
·Cardiovascular
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 3, 2014
INQUIRY OPTIMA STEERABLE, 1110-7-7-SM-OPT25
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, IRVINE·Product code DRF·October 5, 2012
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 19, 2015
NAMIC Convenience Kit, UPN H749601314811, REF/Catalog No. 60131481, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
FDA Enforcement
Class II
·Terminated·Navilyst Medical, Inc·March 4, 2015
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024