Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 show TPLC since Back to Search Results
Device arthroscope
Regulation Description Arthroscope.
Definition Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product CodeHRX
Regulation Number 888.1100
Device Class 2


Premarket Reviews
ManufacturerDecision
ALLEVION MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
CIT ORTHO
  SUBSTANTIALLY EQUIVALENT 1
CLARUS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
DEPUY MITEK, INC.
  SUBSTANTIALLY EQUIVALENT 1
E SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
EBERLE GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
HAND BIOMECHANICS LAB, INC.
  SUBSTANTIALLY EQUIVALENT 2
HEMODIA SAS
  SUBSTANTIALLY EQUIVALENT 2
HYDROCISION, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTRAVU, INC.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CHANGMEI MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JOINT PRESERVATION INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
LESSPINE INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1
MEDIMAGING INTEGRATED SOLUTION, INC (MIIS)
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 1
MICROAIRE SURGICAL INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 2
OK MEDINET KOREA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PRISTINE SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
PROVIDENCE MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
RAFAEL MEDICAL DEVICES, LLC
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI LANGE MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SONEX HEALTH
  SUBSTANTIALLY EQUIVALENT 1
TAEYEON MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRICE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VERTOS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
W.O.M. WORLD OF MEDICINE GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1908 1909
2022 1406 1407
2023 1852 1852
2024 2427 2430
2025 2105 2105
2026 476 476

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1429 1430
Display or Visual Feedback Problem 982 982
Optical Problem 939 939
Use of Device Problem 854 854
Increase in Pressure 666 667
Electrical /Electronic Property Problem 454 455
Crack 408 408
Improper Flow or Infusion 407 407
Infusion or Flow Problem 404 404
Pressure Problem 364 364
Overheating of Device 361 361
Detachment of Device or Device Component 359 359
Output Problem 359 359
Scratched Material 309 309
Appropriate Term/Code Not Available 263 263
Device-Device Incompatibility 248 248
Mechanical Problem 225 225
Material Rupture 218 218
Leak/Splash 217 217
Mechanical Jam 210 210
Poor Quality Image 203 203
Defective Device 188 188
Excess Flow or Over-Infusion 180 180
Physical Resistance/Sticking 171 171
Overfill 165 165
Device Contaminated During Manufacture or Shipping 160 160
Noise, Audible 150 150
Material Deformation 149 149
Electrical Shorting 140 140
Device Remains Activated 134 134
Material Frayed 93 93
Adverse Event Without Identified Device or Use Problem 87 87
Suction Failure 83 83
Material Disintegration 81 81
Fracture 79 80
No Flow 75 75
Contamination /Decontamination Problem 74 74
Material Fragmentation 73 73
Fogging 69 69
No Display/Image 68 68
Material Integrity Problem 68 68
Intermittent Loss of Power 60 60
Inflation Problem 59 59
Blocked Connection 56 56
Power Problem 50 50
Mechanics Altered 50 50
Pumping Problem 47 47
Unintended Movement 46 46
Material Twisted/Bent 45 45
Unexpected Shutdown 45 45

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9367 9370
Insufficient Information 360 360
Swelling/ Edema 202 202
Extravasation 155 156
Foreign Body In Patient 92 92
Unspecified Tissue Injury 26 27
Device Embedded In Tissue or Plaque 17 17
Hematoma 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Burn(s) 14 14
Unspecified Infection 13 13
Pain 12 12
Hemorrhage/Bleeding 11 11
Laceration(s) 9 9
Cerebrospinal Fluid Leakage 7 7
Inflammation 6 6
Loss of Range of Motion 6 6
Pneumothorax 5 5
Infiltration into Tissue 4 4
Numbness 4 4
Failure of Implant 4 4
Neuropathy 3 3
Nerve Damage 3 3
Bone Fracture(s) 3 3
Joint Dislocation 3 3
Cardiac Arrest 2 2
Spinal Column Injury 2 2
Post Operative Wound Infection 2 2
Movement Disorder 2 2
Rupture 2 2
Paralysis 2 2
Muscle Weakness 2 2
Spinal Cord Injury 2 2
Superficial (First Degree) Burn 2 2
Inadequate Osseointegration 2 2
Muscle/Tendon Damage 2 2
Shock 2 2
Urinary Tract Infection 1 1
Pulmonary Embolism 1 1
Vertebral Fracture 1 1
Respiratory Failure 1 1
Low Blood Pressure/ Hypotension 1 1
No Consequences Or Impact To Patient 1 1
Bacterial Infection 1 1
Impaired Healing 1 1
Intervertebral Disc Compression or Protrusion 1 1
Cardiovascular Insufficiency 1 1
Tissue Damage 1 1
Skin Infection 1 1
Non-union Bone Fracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ADRIA SRL II Oct-19-2021
2 Karl Storz Endoscopy II Nov-25-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Mar-25-2025
4 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
5 ReNovo, Inc. II Mar-02-2021
6 WOM World Of Medicine AG II Jul-01-2024
-
-