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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device arthroscope
Regulation Description Arthroscope.
Product CodeHRX
Regulation Number 888.1100
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 4
ACCUMED SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
AESCULAP
  1
  SUBSTANTIALLY EQUIVALENT 2
ALLIANCE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 28
ARTHRO KINETICS INC.
  SUBSTANTIALLY EQUIVALENT 2
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 7
ASPEN LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 4
BAYLIS MEDICAL CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 5
BioVision Technologies, LLC
  SUBSTANTIALLY EQUIVALENT 3
BLACKSTONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BLAZEJEWSKI MEDI-TECH GMBH
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 9
CLARUS MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONMED
  SUBSTANTIALLY EQUIVALENT 4
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 6
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 4
EBI, L.P.
  SUBSTANTIALLY EQUIVALENT 2
EFS EBERLE FEINWERKTECHNISCHE SYSTEME
  SUBSTANTIALLY EQUIVALENT 2
ELLMAN INT'L INC.
  SUBSTANTIALLY EQUIVALENT 1
ENDIUS, INC.
  SUBSTANTIALLY EQUIVALENT 9
GAMBRO
  SUBSTANTIALLY EQUIVALENT 2
HOOGLAND SPINE PRODUCTS GMBH
  SUBSTANTIALLY EQUIVALENT 2
HYDROCISION
  SUBSTANTIALLY EQUIVALENT 6
JG MEDICAL PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 33
KYPHON, INC.
  SUBSTANTIALLY EQUIVALENT 4
LINVATEC
  SUBSTANTIALLY EQUIVALENT 19
MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDISISS
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 13
MICROAIRE
  SUBSTANTIALLY EQUIVALENT 2
MITEK
  SUBSTANTIALLY EQUIVALENT 3
MYELOTEC, INC.
  SUBSTANTIALLY EQUIVALENT 2
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 2
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 3
OPTUS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ORTHOPEDIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 6
OSTEOBIOLOGICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRECISION OPTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
REMA MEDIZINTECHNIK GMBH.
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 14
RZ MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SCHOLLY FIBEROPTIC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  2
  SUBSTANTIALLY EQUIVALENT 17
SOFAMOR DANEK
  1
  SUBSTANTIALLY EQUIVALENT 3
SOPRO
  SUBSTANTIALLY EQUIVALENT 1
SPINAL DEVICES, LLC
  SUBSTANTIALLY EQUIVALENT 1
STERILMED
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 18
SURGICAL NAVIGATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
Symbiosis Corp.
  SUBSTANTIALLY EQUIVALENT 2
T. KOROS SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
  3
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 4
THEKEN SPINE
  SUBSTANTIALLY EQUIVALENT 1
TRANS1
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 5
UTAH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VANGUARD MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VERTIFLEX
  SUBSTANTIALLY EQUIVALENT 1
VISIONSENSE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
VITAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
W. LORENZ SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 3
W.O.M. WORLD OF MEDICINE AG
  SUBSTANTIALLY EQUIVALENT 3
XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Unknown (for use when the device problem is not known) 483
Tip breakage 187
Metal shedding debris 167
Not Applicable 80
Break 69
Material fragmentation 52
Leak 41
Device, or device fragments remain in patient 40
Overheating of device or device component 39
Detachment of device or device component 37
Foreign material 34
Device operates differently than expected 29
No Information 25
Device Issue 24
No Known Device Problem 24
Disassembly 23
Material rupture 23
Device remains activated 22
Increase in pressure 13
Detachment of device component 12
Pressure issue 12
Device inoperable 8
Fluid leak 7
Sharp/jagged/rough/etched/scratched 6
Defective item 5
Burn of device or device component 5
Malfunction 5
Device displays error message 5
Use of Device Issue 5
No code available 5
Smoking 4
Component missing 4
Failure to advance 4
Fracture 4
Device or device fragments location unknown 4
Noise, Audible 4
Hole in material 4
Excess flow or overinfusion 3
Material separation 3
Increased pump speed 3
Unstable 3
Vibration 3
Failure to pump 3
Fogging 3
Unintended energization 3
Heat 2
Melted 2
No display or display failure 2
Deflation issue 2
Low impedance 2
Material integrity issue 2
Low readings 2
Bent 2
Material disintegration 2
False reading from device non-compliance 2
Improper flow or infusion 2
Cut in material 2
Burrs, breakage of 2
Failure to conduct 2
Failure to separate 2
Item contaminated during manufacturing or shipping 2
Material deformation 2
Image display error 2
Normal 2
Decrease in pressure 2
Fitting problem 1
Arcing 1
Shock, electrical 1
Misplacement 1
Foreign material present in device 1
Device packaging compromised 1
Warning light, incorrect 1
Method, improper/incorrect 1
Material opacification 1
Device clogged 1
Failure to deploy 1
Flaked 1
Monitor failure 1
Device damaged prior to use 1
Device alarm system issue 1
Automatic injection system overinfusion 1
Device markings issue 1
Manufacturing or shipping issue associated with device 1
Torn material 1
Mechanical issue 1
Pumping stopped 1
Reuse 1
Implant, removal of 1
Inaccurate delivery 1
Component(s), broken 1
Crack 1
Incorrect display 1
Difficult to remove 1
Laparoscopic sterilization 1
Interference 1
Pre or post-pumping problem 1
Failure to prime 1
Contamination during use 1
Injector system failure, overinfusion of 1
Defective component 1
Total Device Problems 1614

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 1 0 0 0 0 0 0 0
Class II 0 5 4 3 4 1 5 2 2 2
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 ArthroCare Corporation II Sep-16-2008
2 Ascent Healthcare Solutions II Feb-03-2012
3 Ascent Healthcare Solutions, Inc. II Sep-19-2008
4 Biomet, Inc. II Mar-07-2011
5 Customed, Inc II Sep-03-2015
6 DePuy Mitek, Inc., a Johnson & Johnson Co. II Jan-15-2016
7 DePuy Mitek, Inc., a Johnson & Johnson Co. II Nov-08-2013
8 Instratek, Incorporated II Dec-22-2015
9 Linvatec Corp. dba ConMed Linvatec II Jul-10-2013
10 Linvatec Corp. dba ConMed Linvatec II Aug-24-2010
11 Linvatec Corp. dba ConMed Linvatec II Aug-09-2010
12 Linvatec Corp. dba ConMed Linvatec I Oct-01-2009
13 Medtronic Spine LLC (formerly Kyphon Inc.) II Sep-09-2011
14 Medtronic Spine LLC, formerly Kyphon Inc II May-11-2009
15 Myelotec, Inc. II Apr-10-2008
16 Richard Wolf Medical Instruments Corp. II Feb-09-2016
17 Smith & Nephew, Inc. Endoscopy Division II Sep-21-2009
18 Smith & Nephew, Inc. Endoscopy Division II Sep-21-2008
19 Stryker Endoscopy II Jun-25-2014
20 Stryker Endoscopy II Apr-08-2011
21 Stryker Endoscopy II Dec-28-2010
22 Stryker Endoscopy II Jan-21-2009
23 Stryker Endoscopy II Jan-16-2009
24 Stryker Endoscopy II Apr-02-2008
25 Stryker Instruments Div. of Stryker Corporation II Nov-01-2013
26 Stryker Instruments Division of Stryker Corporation II Mar-28-2011
27 Surgical Instrument Service And Savings, Inc. II Jul-01-2013
28 The Anspach Effort, Inc. II Jun-25-2014
29 Zimmer, Inc. II Apr-01-2013

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