• 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 cover, barrier, protective
Regulation Description Surgical drape and drape accessories.
Product CodeMMP
Regulation Number 878.4370
Device Class 2

MDR Year MDR Reports MDR Events
2015 3 3
2016 1 1
2018 1 1
2019 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Delivered as Unsterile Product 2 2
Material Puncture/Hole 2 2
Structural Problem 1 1
Split 1 1
Packaging Problem 1 1
Torn Material 1 1
Break 1 1
False Negative Result 1 1
Unsealed Device Packaging 1 1
Handpiece 1 1
Cover 1 1
Contamination 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 3 3
No Known Impact Or Consequence To Patient 3 3
No Information 3 3
Test Result 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Covidien LLC II Mar-04-2017
2 NOVADAQ TECHNOLOGIES INC. II Sep-28-2017
3 Penner Mfg Inc II Mar-20-2015
4 Stryker Corporation II May-07-2020
5 Sybron Dental Specialties II Mar-18-2015
-
-