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 microtools, assisted reproduction (pipettes)
Product CodeMQH
Regulation Number 884.6130
Device Class 2


Premarket Reviews
ManufacturerDecision
VITROMED GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 4 4
2021 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Nonstandard Device 4 4
Microbial Contamination of Device 3 3
Product Quality Problem 2 2
Insufficient Information 2 2
Contamination 1 1
Defective Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 7 7
No Known Impact Or Consequence To Patient 4 4
No Clinical Signs, Symptoms or Conditions 2 2
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CooperSurgical, Inc. II May-17-2019
-
-