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 ophthalmic needle
Regulation Description Hypodermic single lumen needle.
Definition An Ophthalmic Needle is a needle intended for intraocular injections. The device should be used by health care professionals to perform injections into the eye.
Product CodeQYM
Regulation Number 880.5570
Device Class 2


Premarket Reviews
ManufacturerDecision
TERUMO EUROPE N.V.
  SUBSTANTIALLY EQUIVALENT 1
TSK LABORATORY INTERNATIONAL JAPAN KK
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2025 9 9
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7 7
Contamination of Device Ingredient or Reagent 4 4
Lack of Effect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Endophthalmitis 5 5
Inflammation 3 3
Vitritis 3 3
Loss of Vision 2 2
Uveitis 2 2
Intraocular Infection 1 1

-
-