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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 5949
Spring loading mechanism problem 169
Needle, unsheathed 113
Incorrect or inadequate result 74
Delivered as unsterile product 69
Material fragmentation 31
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 15
Failure to obtain samples 11
Failure to fire 9
Unknown (for use when the device problem is not known) 8
Device contamination with blood or blood product 6
Unable to obtain readings 6
Needle, separation 5
Break 4
Component missing 4
Use of Device Issue 3
Improper or incorrect procedure or method 3
Failure to prime 3
Inaccurate delivery 3
Reuse 3
Delivery system failure 3
Device or device fragments location unknown 2
Device markings issue 2
Expiration date error 2
Device operates differently than expected 2
Not Applicable 2
Failure to cut 1
Shielding failure 1
Misfire 1
Fail-safe mechanism issue 1
Sterility 1
Pierce 1
Defective component 1
Contamination during use 1
Product quality issue 1
Device inoperable 1
Manufacturing or shipping issue associated with device 1
Malfunction 1
Burn of device or device component 1
Loose or intermittent connection 1
Needle, dull 1
Incorrect display 1
Mechanical issue 1
Failure to unfold or unwrap 1
Size incorrect for patient 1
Device misassembled during manufacturing or shipping 1
Failure of device to self-test 1
Detachment of device component 1
Unsealed device packaging 1
Device remains implanted 1
Material separation 1
Inadequate training 1
Out-of-box failure 1
Incomplete or missing packaging 1
Device packaging compromised 1
Total Device Problems 6649

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