10 results
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19ms
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Sources: EU EUDAMED, US FDA
ALOKA 680 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MOR® Surgical Kit - No Tools
FDA UDI
STERNGOLD DENTAL LLC·00841549118432·Intended to be used during implant surgical pro...
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221113467·3M™ Victory Series™ Second Molar Bands, 905-252...
RASTRONICS CCI 10/3 HEARING AID ANALYSIS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
HEWLETT-PACKARD SERIES OF DISPOSABLE NIBP CUFFS
FDA 510(k)
FDA Class 2
·Cardiovascular
OLYMPUS THUNDERBEAT 5 MM, 35 CM, FRONT ACTUATE
FDA Adverse Event
Malfunction
·OLYMPUS MED SYSTEM CORP·Product code GEI·May 28, 2014
ISOFLEX OPTIM LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 9, 2013
UNICEL® DXC 800 SYNCHRON® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code CGA·November 22, 2010
Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
FDA Enforcement
Class I
·Terminated·Cook Inc.·March 2, 2016
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015