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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device marker, radiographic, implantable
Regulation Description Implantable clip.
Product CodeNEU
Regulation Number 878.4300
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOFORM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 3
CARBON MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 5
CIANNA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CYTOPHIL INC
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 2
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
INRAD
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL DEVICE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
MRI DEVICES CORP.
  SUBSTANTIALLY EQUIVALENT 1
SENORX, INC.
  SUBSTANTIALLY EQUIVALENT 7
SOMATEX MEDICAL TECHNOLOGIES GMBH
  SUBSTANTIALLY EQUIVALENT 3
SUROS SURGICAL SYSTEMS, INC, A HOLOGIC COMPANY
  SUBSTANTIALLY EQUIVALENT 3
W. LORENZ SURGICAL
  SUBSTANTIALLY EQUIVALENT 2
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device or device component damaged by another device 59
No code available 36
No Known Device Problem 24
Migration of device or device component 17
Failure to deploy 15
Material fragmentation 14
Patient-device incompatibility 13
Bent 9
Break 7
Delivered as unsterile product 7
Detachment of device or device component 6
Artifact 5
No Information 4
Nonstandard device or device component 4
Replace 4
Retraction problem 3
Improper or incorrect procedure or method 3
Kinked 2
Use of Device Issue 2
Deployment issue 1
Device operates differently than expected 1
Incorrect device or component shipped 1
Detachment of device component 1
Difficult to remove 1
Component missing 1
Failure to separate 1
Device displays error message 1
Failure to fire 1
Material separation 1
Tip breakage 1
Total Device Problems 245

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 1 0 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vascular Inc II Jun-10-2013
2 Kapp Surgical Instrument Inc II Jul-07-2011

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