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 pill crusher/cutter
Definition A device used to cut or crush medication to aid in consumption. The device is intended to only be used with medications that are labeled as acceptable for crushing or cutting.
Product CodeOHY
Regulation Number 880.6430
Device Class 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 2 2
2021 2 2
2022 7 7
2023 3 3
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4 4
Use of Device Problem 3 3
Crack 1 1
Insufficient Information 1 1
Detachment of Device or Device Component 1 1
Product Quality Problem 1 1
Unsealed Device Packaging 1 1
Contamination /Decontamination Problem 1 1
Degraded 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10 10
Laceration(s) 5 5
No Code Available 1 1
Not Applicable 1 1
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Jun-24-2022
-
-