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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 6535
Spring loading mechanism problem 169
Needle, unsheathed 113
Delivered as unsterile product 74
Incorrect or inadequate result 74
Material fragmentation 40
Replace 27
Device, or device fragments remain in patient 22
No Known Device Problem 20
Other (for use when an appropriate device code cannot be identified) 19
Incorrect or inadequate test results 18
Detachment of device or device component 18
Material Protrusion 17
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
Component missing 5
Device operates differently than expected 5
Use of Device Issue 4
Break 4
Failure to prime 3
Improper or incorrect procedure or method 3
Reuse 3
Material separation 3
Delivery system failure 3
Inaccurate delivery 3
Expiration date error 2
Out-of-box failure 2
Device or device fragments location unknown 2
Device markings issue 2
Not Applicable 2
Detachment of device component 2
Contamination during use 1
Disassembly 1
Incorrect display 1
Loose or intermittent connection 1
Mechanical issue 1
Needle, dull 1
Product quality issue 1
Burn of device or device component 1
Unsealed device packaging 1
Pierce 1
Shielding failure 1
Size incorrect for patient 1
Device remains implanted 1
Sterility 1
Inadequate training 1
Device inoperable 1
Failure to unfold or unwrap 1
Device misassembled during manufacturing or shipping 1
Incomplete or missing packaging 1
Defective component 1
Misfire 1
Malfunction 1
Failure to cut 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
Total Device Problems 7266

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