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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device neurological stereotaxic instrument
Regulation Description Stereotaxic instrument.
Product CodeHAW
Regulation Number 882.4560
Device Class 2


Premarket Reviews
ManufacturerDecision
7D SURGICAL ULC
  SUBSTANTIALLY EQUIVALENT 1
BAYER MEDICAL CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BRAIN NAVI BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 8
CLARONAV
  SUBSTANTIALLY EQUIVALENT 1
CLEARPOINT NEURO, INC.
  SUBSTANTIALLY EQUIVALENT 10
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
INTRAVENT MEDICAL PARTNERS
  SUBSTANTIALLY EQUIVALENT 1
INTRAVENT MEDICAL PARTNERS, LP
  SUBSTANTIALLY EQUIVALENT 1
KOH YOUNG TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
LOCALITE GMBH
  SUBSTANTIALLY EQUIVALENT 1
MEDIVIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTECH S.A.S
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC NAVIGATION
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NAVIGATION, INC.
  SUBSTANTIALLY EQUIVALENT 4
NAVINETICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
PAJUNK GMBH MEDIZINTECHNOLOGIE
  SUBSTANTIALLY EQUIVALENT 2
PHASOR HEALTH, LLC
  SUBSTANTIALLY EQUIVALENT 1
SINOVATION (BEIJING) MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
THERATAXIS, LLC
  SUBSTANTIALLY EQUIVALENT 1
TONICA ELEKTRONIK A/S
  SUBSTANTIALLY EQUIVALENT 1
ZETA SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
ZETA SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 2827 2830
2022 1929 1966
2023 2510 2535
2024 3755 3760
2025 3484 3484
2026 452 452

Device Problems MDRs with this Device Problem Events in those MDRs
Application Program Freezes, Becomes Nonfunctional 2627 2641
Application Program Problem 2502 2509
Mechanical Problem 2321 2323
Device Sensing Problem 2275 2284
Incorrect, Inadequate or Imprecise Result or Readings 1519 1527
Imprecision 1382 1401
Display or Visual Feedback Problem 1367 1370
Communication or Transmission Problem 1062 1063
Material Integrity Problem 778 784
Adverse Event Without Identified Device or Use Problem 769 772
Environmental Compatibility Problem 651 653
Use of Device Problem 605 607
Connection Problem 551 551
Human-Device Interface Problem 473 480
Unexpected Shutdown 346 347
Electrical /Electronic Property Problem 195 195
Computer Software Problem 180 180
Incorrect Measurement 161 161
Unintended Application Program Shut Down 143 144
Power Problem 137 137
Output Problem 85 86
Failure to Power Up 77 77
Material Fragmentation 72 72
No Device Output 68 70
Fracture 63 64
Failure to Read Input Signal 60 60
Computer Operating System Problem 57 57
Delayed Program or Algorithm Execution 53 53
Excessive Heating 47 47
Activation, Positioning or Separation Problem 46 46
Mechanical Jam 41 41
Insufficient Information 40 41
Break 37 37
Improper or Incorrect Procedure or Method 36 36
Mechanics Altered 35 35
Patient Data Problem 31 31
Naturally Worn 30 30
Failure to Shut Off 29 29
Malposition of Device 26 26
Data Problem 23 24
Material Twisted/Bent 23 23
Positioning Problem 21 23
Deformation Due to Compressive Stress 21 21
Audible Prompt/Feedback Problem 20 20
Device Handling Problem 18 18
Unintended Movement 17 17
Unintended Collision 16 16
Overheating of Device 15 15
Component Missing 15 15
Material Deformation 14 14

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14214 14276
Unspecified Tissue Injury 217 218
Insufficient Information 149 151
Hemorrhage/Bleeding 96 96
Intracranial Hemorrhage 72 72
Cerebrospinal Fluid Leakage 66 67
Unspecified Nervous System Problem 65 66
Unspecified Infection 60 60
No Consequences Or Impact To Patient 48 48
Hematoma 37 37
Muscle Weakness 35 36
Pain 34 34
Dysphasia 32 32
Convulsion/Seizure 28 28
Post Operative Wound Infection 28 28
Paralysis 21 22
No Patient Involvement 20 20
Cognitive Changes 19 20
Swelling/ Edema 18 18
Nerve Damage 18 18
Paresis 17 18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Bacterial Infection 16 16
Headache 16 16
Foreign Body In Patient 16 16
Hydrocephalus 15 15
Numbness 15 16
Ambulation Difficulties 13 13
Thrombosis/Thrombus 13 13
Paresthesia 13 14
Loss of Range of Motion 12 12
Bone Fracture(s) 12 12
Device Embedded In Tissue or Plaque 11 11
Meningitis 10 10
Visual Impairment 10 10
Perforation 9 9
Cardiac Arrest 8 8
Memory Loss/Impairment 8 8
Pleural Effusion 8 8
Brain Injury 8 8
Unintended Radiation Exposure 7 7
Confusion/ Disorientation 7 7
Abscess 7 7
Urinary Tract Infection 6 6
Spinal Column Injury 6 6
Seroma 6 6
Fever 6 6
Visual Disturbances 6 6
Spinal Cord Injury 6 6
Erosion 6 6

Recalls
Manufacturer Recall Class Date Posted
1 Elekta Instrument AB I Nov-06-2024
2 Elekta Instrument AB I Apr-16-2024
3 Elekta Instrument AB II Mar-30-2023
4 Elekta, Inc. II Nov-05-2025
5 FHC, Inc. I Nov-08-2024
6 Globus Medical, Inc. II Feb-06-2024
7 Howmedica Osteonics Corp. II Dec-19-2025
8 MEDTECH SAS I Oct-25-2021
9 Medtronic Navigation, Inc. I May-09-2024
10 Medtronic Navigation, Inc. I Nov-10-2023
11 Medtronic Navigation, Inc. I Jun-02-2023
12 Medtronic Navigation, Inc. I Jun-02-2023
13 Medtronic Navigation, Inc. II Jan-30-2023
14 Medtronic Navigation, Inc. I Dec-22-2021
15 Medtronic Navigation, Inc. II Dec-22-2021
16 Medtronic Xomed, Inc. II Oct-21-2021
17 Navinetics Inc II Apr-04-2024
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