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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, ultrasonic surgical
Product CodeLFL
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 2
ETHICON ENDO-SURGERY, LLC
  SUBSTANTIALLY EQUIVALENT 3
HUNAN HANDLIKE MINIMALLY INVASIVE SURGERY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
KATALYST SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
MICONVEY TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MISONIX INC.
  SUBSTANTIALLY EQUIVALENT 2
MISONIX, LLC, A BIOVENTUS COMPANY
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI SAINTS SAGES SURGICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMTP TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SMTP TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SRA DEVELOPMENTS LTD
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
STRYKER INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 1
SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TENDONOVA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRICE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 2934 2988
2021 3288 3333
2022 3422 3470
2023 4215 4245
2024 4017 4063
2025 1533 1556

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 5605 5605
Failure to Read Input Signal 4354 4354
Detachment of Device or Device Component 2892 2892
Difficult or Delayed Activation 1010 1010
Break 931 931
Material Integrity Problem 847 847
Activation, Positioning or Separation Problem 460 460
Insufficient Information 434 434
Fracture 411 435
Inappropriate or Unexpected Reset 371 371
Adverse Event Without Identified Device or Use Problem 363 363
Device Alarm System 299 299
Failure to Fire 280 280
Activation Problem 258 258
Patient Device Interaction Problem 239 239
Overheating of Device 208 324
Protective Measures Problem 179 179
Delivered as Unsterile Product 177 177
Peeled/Delaminated 173 173
Noise, Audible 151 151
Mechanical Problem 131 131
Difficult to Open or Close 118 118
Device Displays Incorrect Message 113 113
Output Problem 104 104
Excessive Heating 92 92
Inability to Irrigate 83 189
Failure to Disconnect 82 82
Intermittent Energy Output 81 81
Defective Device 70 70
No Apparent Adverse Event 62 62
Self-Activation or Keying 57 57
Appropriate Term/Code Not Available 54 54
Crack 51 51
Degraded 47 47
Tear, Rip or Hole in Device Packaging 43 43
Failure to Deliver Energy 39 39
Device Fell 39 39
Therapeutic or Diagnostic Output Failure 37 37
Smoking 36 36
Melted 35 35
Use of Device Problem 31 31
Failure to Cut 27 27
Naturally Worn 26 26
Manufacturing, Packaging or Shipping Problem 25 25
Failure of Device to Self-Test 22 22
Incorrect, Inadequate or Imprecise Result or Readings 22 22
Device Remains Activated 20 20
Suction Problem 20 20
Power Problem 19 19
Connection Problem 19 19

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16112 16331
No Consequences Or Impact To Patient 2282 2312
Insufficient Information 284 309
Hemorrhage/Bleeding 235 235
Burn(s) 94 122
No Code Available 83 83
Blood Loss 79 79
No Known Impact Or Consequence To Patient 75 85
No Patient Involvement 66 102
Foreign Body In Patient 55 55
Pain 52 52
Fistula 45 45
Unspecified Infection 42 42
Hematoma 42 42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 40 40
Injury 39 39
Abscess 32 32
Failure to Anastomose 26 26
Obstruction/Occlusion 25 25
Unspecified Tissue Injury 24 24
Post Operative Wound Infection 23 23
Unintended Radiation Exposure 20 23
Seroma 19 19
Nerve Damage 19 19
Device Embedded In Tissue or Plaque 18 18
Superficial (First Degree) Burn 17 22
Fever 15 15
Partial thickness (Second Degree) Burn 15 15
Abdominal Pain 14 14
Pleural Effusion 13 13
Swelling/ Edema 13 13
Laceration(s) 12 12
Paresis 12 12
Inflammation 11 11
Perforation 11 11
Anemia 11 11
No Information 10 10
Necrosis 9 9
Burn, Thermal 9 9
Rupture 9 9
Pneumothorax 8 8
Death 8 8
Bacterial Infection 8 8
Pneumonia 7 7
Hernia 7 7
Urinary Retention 7 7
Vomiting 7 7
Impaired Healing 7 7
Speech Disorder 7 7
Wound Dehiscence 6 6

Recalls
Manufacturer Recall Class Date Posted
1 Covidien Llc II Dec-03-2021
2 Covidien Llc II Aug-10-2021
3 Ethicon Endo-Surgery Inc II Aug-26-2021
4 Integra LifeSciences Corp. II Jun-21-2024
5 Olympus Corporation of the Americas II Jan-21-2025
6 Olympus Corporation of the Americas II Oct-12-2023
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