Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device temporary, internal use hemostatic
Definition Intended to control severely bleeding wounds
Product CodePOD
Regulation Number 878.4454
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVAMEDICA INC.
  SUBSTANTIALLY EQUIVALENT 1
BEEKEN BIOMEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
Z-MEDICA, LLC
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Entrapment of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beeken Biomedical, LLC II Nov-26-2021
-
-