• 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 apparatus, exhaust, surgical
Regulation Description Air-handling apparatus for a surgical operating room.
Product CodeFYD
Regulation Number 878.5070
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO PROTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
LINA MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 1
MEGADYNE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Self-Activation or Keying 5
Electrical /Electronic Property Problem 3
Adverse Event Without Identified Device or Use Problem 3
Suction Problem 2
Overheating of Device 2
Device Remains Activated 2
Intermittent Energy Output 1
Smoking 1
Partial Blockage 1
Sparking 1
False Alarm 1
Unintended power up 1
Leak / Splash 1
No Audible Prompt / Feedback 1
Noise, Audible 1
Total Device Problems 26

Recalls
Manufacturer Recall Class Date Posted
1 Microtek Medical Inc II Mar-27-2015
2 Stryker Instruments Div. of Stryker Corporation II Sep-01-2015

-
-