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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lancet, blood
Regulation Description Manual surgical instrument for general use.
Product CodeFMK
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
GAINOR MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
HOME DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL TECHNIDYNE CORP.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 2
KULZER
  SUBSTANTIALLY EQUIVALENT 1
PALCO LABS, INC
  SUBSTANTIALLY EQUIVALENT 1
PELIKAN TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
PRIMROSE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Retraction problem 6031
Spring loading mechanism problem 169
Needle, unsheathed 113
Incorrect or inadequate result 74
Delivered as unsterile product 70
Material fragmentation 34
Replace 27
Device, or device fragments remain in patient 22
Other (for use when an appropriate device code cannot be identified) 19
Detachment of device or device component 17
Material Protrusion 17
No Known Device Problem 17
Incorrect or inadequate test results 16
Failure to obtain samples 11
Failure to fire 9
Unknown (for use when the device problem is not known) 8
Unable to obtain readings 6
Device contamination with blood or blood product 6
Needle, separation 5
Break 4
Component missing 4
Inaccurate delivery 3
Delivery system failure 3
Failure to prime 3
Reuse 3
Use of Device Issue 3
Improper or incorrect procedure or method 3
Material separation 2
Device markings issue 2
Device operates differently than expected 2
Expiration date error 2
Not Applicable 2
Device or device fragments location unknown 2
Misfire 1
Failure to cut 1
Malfunction 1
Out-of-box failure 1
Incomplete or missing packaging 1
Device packaging compromised 1
Fail-safe mechanism issue 1
Failure of device to self-test 1
Manufacturing or shipping issue associated with device 1
Device misassembled during manufacturing or shipping 1
Shielding failure 1
Size incorrect for patient 1
Defective component 1
Sterility 1
Inadequate training 1
Device inoperable 1
Failure to unfold or unwrap 1
Product quality issue 1
Device remains implanted 1
Unsealed device packaging 1
Pierce 1
Burn of device or device component 1
Detachment of device component 1
Contamination during use 1
Incorrect display 1
Loose or intermittent connection 1
Mechanical issue 1
Needle, dull 1
Total Device Problems 6737

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