10 results
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17ms
·
Sources: EU EUDAMED, US FDA
BONDABLE RETAINER AND SPACE MAINTAINER
FDA 510(k)
FDA Class 1
·Dental
ATLANTIS ABUTMENT FOR NOBEL BIOCARE ACTIVE IMPLANT, ATLANTIS GEMINI ABUTMENT, GEMINI + ABUTMENT
FDA 510(k)
FDA Class 2
·Dental
Basal-IQ Technology
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LEAD EXTRACTION BYRD POLYPROPYLENE EXTRA LONG DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code GCC·January 22, 2021
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·September 1, 2011
ONE LINK NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLAC
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FPA·June 13, 2014
LIGAMAX-5MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·November 8, 2010
UNKNOWN LEFT HIP NECK
FDA Adverse Event
Injury
·STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI·Product code JDI·December 21, 2012
LEAD EXTRACTION BYRD POLYPROPYLENE DILATOR SHEATH SET
FDA Adverse Event
Malfunction
·COOK VANDERGRIFT INC·Product code GCC·March 9, 2022
GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 29, 2012