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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device motor, drill, electric
Regulation Description Electric cranial drill motor.
Product CodeHBC
Regulation Number 882.4360
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 2
BIOPLATE, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONMED
  SUBSTANTIALLY EQUIVALENT 1
LINVATEC
  SUBSTANTIALLY EQUIVALENT 2
MEDICON, E.G.
  SUBSTANTIALLY EQUIVALENT 1
NAKANISHI, INC.
  SUBSTANTIALLY EQUIVALENT 2
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Overheating of device or device component 222
Device inoperable 144
Break 110
Device displays error message 94
Device operates differently than expected 54
Temperature issue 37
Noise, Audible 36
Naturally worn 25
Difficult to insert 22
Defective item 21
Vibration 15
Smoking 14
Component missing 14
Device stops intermittently 12
Fitting problem 12
Sticking 11
Loss of power 11
Loose or intermittent connection 11
Failure to power-up 9
Material separation 9
Bent 9
Slippage of device or device component 8
Crack 7
Detachment of device or device component 7
Moisture damage 7
Positioning Issue 7
Detachment of device component 7
Burn of device or device component 5
Component falling 5
Torn material 4
Fluid leak 4
Mechanical issue 4
Material deformation 4
Hole in material 4
Mechanical jam 4
Material integrity issue 4
Power source issue 4
Defective component 4
Corrosion 4
Fracture 3
Degraded 3
Leak 3
Item contaminated during manufacturing or shipping 3
Air leak 2
Device markings issue 2
No code available 2
Electrical issue 2
Self-activation or keying 2
Connection issue 2
Unstable 2
Failure to advance 1
Device sensing issue 1
Burst 1
Migration of device or device component 1
Difficult to remove 1
Disinfection or Sterilization Issue at User Location 1
Occlusion within device 1
Device remains activated 1
Metal shedding debris 1
Failure to cut 1
Failure to auto stop 1
Material Distortion 1
Mechanics altered 1
Erratic display 1
Device alarm system issue 1
Dull 1
Malposition of device 1
Device or device fragments location unknown 1
No Information 1
Cut in material 1
Split 1
Failure to shut off 1
Material fragmentation 1
Device emits odor 1
Contamination of device ingredient or reagent 1
Foreign material present in device 1
Peeled 1
Unintended movement 1
Total Device Problems 1039

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 3 0 1 2 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Inc II Mar-02-2011
2 The Anspach Effort, Inc. II Feb-02-2015
3 The Anspach Effort, Inc. II Jun-25-2014
4 The Anspach Effort, Inc. II Jan-27-2014
5 The Anspach Effort, Inc. II Nov-13-2013
6 The Anspach Effort, Inc. II Sep-14-2011
7 The Anspach Effort, Inc. II Sep-13-2011

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