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 retractor, self-retaining, for neurosurgery
Product CodeGZT
Regulation Number 882.4800
Device Class 2


Premarket Reviews
ManufacturerDecision
MINNETRONIX NEURO, INC.
  SUBSTANTIALLY EQUIVALENT 1
THOMPSON SURGICAL INSTRUMENTS INC.
  SUBSTANTIALLY EQUIVALENT 1
VYCOR MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 3 3
2021 2 2
2022 4 4
2023 2 2
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Break 6 6
Mechanical Problem 2 2
Crack 2 2
Optical Problem 2 2
Material Separation 2 2
Device Slipped 1 1
Material Twisted/Bent 1 1
Device Reprocessing Problem 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16 16
No Consequences Or Impact To Patient 3 3

-
-