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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.
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
ADVANCED MEDICAL SYSTEMS GROUP SRL
  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 1
HEMODIA SAS
  SUBSTANTIALLY EQUIVALENT 3
HYDROCISION, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTRAVU, INC.
  SUBSTANTIALLY EQUIVALENT 1
IZI MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CHANGMEI MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL, SARL
  SUBSTANTIALLY EQUIVALENT 1
  1.  K213978  TELIGEN System
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
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
TAEYEON MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRICE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VERTOS MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1706 1706
2021 1908 1908
2022 1407 1407
2023 1852 1852
2024 2427 2427
2025 760 760

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1461 1461
Display or Visual Feedback Problem 834 834
Optical Problem 784 784
Use of Device Problem 758 758
Increase in Pressure 582 582
Electrical /Electronic Property Problem 443 443
Detachment of Device or Device Component 381 381
Improper Flow or Infusion 376 376
Overheating of Device 353 353
Infusion or Flow Problem 349 349
Crack 347 347
Device-Device Incompatibility 312 312
Pressure Problem 306 306
Poor Quality Image 297 297
Output Problem 296 296
Scratched Material 252 252
Electrical Shorting 238 238
Appropriate Term/Code Not Available 232 232
Leak/Splash 223 223
Mechanical Jam 200 200
Mechanical Problem 200 200
Defective Device 181 181
Overfill 172 172
Material Rupture 168 168
Physical Resistance/Sticking 160 160
Device Remains Activated 129 129
Device Contaminated During Manufacture or Shipping 127 127
Excess Flow or Over-Infusion 127 127
Material Deformation 123 123
Noise, Audible 113 113
Adverse Event Without Identified Device or Use Problem 107 107
Corroded 102 102
Material Disintegration 100 100
Suction Failure 98 98
Material Frayed 90 90
No Display/Image 84 84
Fracture 76 76
Contamination /Decontamination Problem 71 71
Intermittent Loss of Power 57 57
Inflation Problem 57 57
Degraded 54 54
Mechanics Altered 50 50
Material Integrity Problem 49 49
Entrapment of Device 47 47
Fluid/Blood Leak 47 47
Unintended Movement 46 46
Pumping Problem 45 45
Connection Problem 44 44
Power Problem 44 44
Unexpected Shutdown 43 43

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8097 8097
No Consequences Or Impact To Patient 714 714
Insufficient Information 326 326
No Known Impact Or Consequence To Patient 238 238
No Patient Involvement 208 208
Swelling/ Edema 144 144
Extravasation 142 142
Foreign Body In Patient 127 127
Not Applicable 106 106
No Information 30 30
Unspecified Tissue Injury 27 27
No Code Available 27 27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Device Embedded In Tissue or Plaque 18 18
Burn(s) 18 18
Hematoma 17 17
Unspecified Infection 14 14
Pain 12 12
Injury 12 12
Hemorrhage/Bleeding 11 11
Swelling 11 11
Laceration(s) 9 9
Bone Fracture(s) 8 8
Cerebrospinal Fluid Leakage 7 7
Inflammation 6 6
Tissue Damage 5 5
Failure of Implant 4 4
Numbness 4 4
Edema 4 4
Loss of Range of Motion 4 4
Infiltration into Tissue 3 3
Nerve Damage 3 3
Joint Dislocation 3 3
Neuropathy 2 2
Movement Disorder 2 2
Post Operative Wound Infection 2 2
Muscular Rigidity 2 2
Spinal Column Injury 2 2
Rupture 2 2
Joint Swelling 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
Low Blood Pressure/ Hypotension 1 1
Extubate 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 Medtronic Sofamor Danek USA Inc II Jun-16-2020
6 ReNovo, Inc. II Mar-02-2021
7 Smith & Nephew, Inc. II Jul-24-2020
8 WOM World Of Medicine AG II Jul-01-2024
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