• 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 Back To Search Results
Device needle, hypodermic, single lumen
Regulation Description Hypodermic single lumen needle.
Product CodeFMI
Regulation Number 880.5570
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
  1.  K913498  MX927 BLOOD TRANSFER DEVICE
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 4
ARTSANA S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
ATRION MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AUTOSAFE-REFELX INC.
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 6
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 8
BD
  SUBSTANTIALLY EQUIVALENT 16
BEMIS HEALTH CARE
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
BUSSE HOSPITAL DISPOSABLES, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
DAEJIN TECH MEDICAL MANUFACTURING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL
  SUBSTANTIALLY EQUIVALENT 1
DISETRONIC MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 4
EXELINT INTERNATIONAL CO
  SUBSTANTIALLY EQUIVALENT 2
EXELINT INTERNATIONAL CO.
  SUBSTANTIALLY EQUIVALENT 2
FACET TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 3
FEEL TECH
  SUBSTANTIALLY EQUIVALENT 2
GAINOR MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GREINER BIO-ONE
  SUBSTANTIALLY EQUIVALENT 5
HAGER WORLDWIDE, INC.
  SUBSTANTIALLY EQUIVALENT 1
HDC CORP.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 4
JMS
  SUBSTANTIALLY EQUIVALENT 3
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 13
KOFU FACTORY OF TERUMO CORP.
  SUBSTANTIALLY EQUIVALENT 2
M&M INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MANAN MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 2
MEADOX
  SUBSTANTIALLY EQUIVALENT 2
MED INSTITUTE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDEX
  SUBSTANTIALLY EQUIVALENT 1
  1.  K913498  MX927 BLOOD TRANSFER DEVICE
MEDICAL DEVICE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDISYSTEM
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE
  SUBSTANTIALLY EQUIVALENT 2
MEGADYNE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MULTI-MED, INC.
  SUBSTANTIALLY EQUIVALENT 2
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 5
NORFOLK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PLEXUS BIOMEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 6
PORTEX, INC.
  SUBSTANTIALLY EQUIVALENT 3
POST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
PYNG MEDICAL
  SUBSTANTIALLY EQUIVALENT 5
RETRACTABLE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
SAGE PRODUCTS
  SUBSTANTIALLY EQUIVALENT 4
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI DOUBLE DOVE INDUSTRIAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHINA CORP.
  SUBSTANTIALLY EQUIVALENT 2
SHINCHANG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIMS
  SUBSTANTIALLY EQUIVALENT 1
SMITHS
  SUBSTANTIALLY EQUIVALENT 9
SPECIALIZED HEALTH PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 18
TRISTATE
  SUBSTANTIALLY EQUIVALENT 1
TYCO HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
ULTIMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VIDACARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 13
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 2
VYGON CORP.
  SUBSTANTIALLY EQUIVALENT 1
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Detachment of device component 290
Break 105
Detachment of device or device component 60
Needle, separation 49
Component(s), broken 47
Device stops intermittently 36
Unknown (for use when the device problem is not known) 33
Bent 30
Material separation 26
Shielding failure 22
Failure to deploy 21
Needle, unsheathed 19
Device operates differently than expected 19
No Known Device Problem 18
Difficult to insert 16
Use of Device Issue 15
Power source issue 14
Fail-safe design failure 14
Other (for use when an appropriate device code cannot be identified) 13
Difficult to remove 13
Device, or device fragments remain in patient 12
Battery issue 11
Retraction problem 11
Material fragmentation 11
No Information 9
Failure to advance 9
Safety interlock(s) inadequate 8
Difficult or delayed activation 8
Slippage of device or device component 7
Tip breakage 7
Failure to capture 6
Material puncture 6
Device or device fragments location unknown 6
Loss of power 6
Failure to separate 6
Disengaged 6
Disconnection 5
Deployment issue 5
Locking mechanism failure 5
Fail-safe mechanism issue 4
Improper or incorrect procedure or method 4
Fracture 4
Loose or intermittent connection 4
Protective measure issue 4
Device Issue 4
Device handling issue 3
Sticking 3
Foreign material present in device 3
Entrapment of device or device component 3
Contamination during use 3
Product quality issue 3
Tear, rip or hole in device packaging 2
Foreign material 2
Dislodged or dislocated 2
Not Applicable 2
Particulates 2
Metal shedding debris 2
Overheating of device or device component 2
Colony forming units 2
Dislodged 2
Leak 2
Air leak 2
Failure to power-up 1
Device remains implanted 1
Medication Error 1
Mechanical jam 1
Size incorrect for patient 1
Material deformation 1
Unintended movement 1
Crack 1
Failure to discharge 1
Difficult to position 1
Defective item 1
Packaging issue 1
Displacement 1
Device alarm system issue 1
Component falling 1
Insufficient flow or underinfusion 1
Device damaged prior to use 1
Blood pooling 1
Dull 1
Malfunction 1
Failure to disconnect 1
Component missing 1
Structural problem 1
Disassembly 1
Difficult to flush 1
Occlusion within device 1
Connection issue 1
Extrusion 1
Failure to sense 1
Physical resistance 1
Migration of device or device component 1
Infusion or flow issue 1
Device inoperable 1
Total Device Problems 1101

-
-