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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 3

MDR Year MDR Reports MDR Events
2021 2827 2830
2022 1929 1966
2023 2510 2535
2024 3755 3760
2025 3484 3484
2026 597 597

Device Problems MDRs with this Device Problem Events in those MDRs
Application Program Freezes, Becomes Nonfunctional 2635 2649
Application Program Problem 2518 2525
Mechanical Problem 2340 2342
Device Sensing Problem 2290 2299
Incorrect, Inadequate or Imprecise Result or Readings 1574 1582
Display or Visual Feedback Problem 1389 1392
Imprecision 1382 1401
Communication or Transmission Problem 1066 1067
Adverse Event Without Identified Device or Use Problem 792 795
Material Integrity Problem 778 784
Environmental Compatibility Problem 651 653
Use of Device Problem 609 611
Connection Problem 552 552
Human-Device Interface Problem 473 480
Unexpected Shutdown 346 347
Electrical /Electronic Property Problem 201 201
Computer Software Problem 181 181
Incorrect Measurement 161 161
Unintended Application Program Shut Down 144 145
Power Problem 138 138
Output Problem 86 87
Material Fragmentation 79 79
Failure to Power Up 78 78
No Device Output 69 71
Fracture 63 64
Failure to Read Input Signal 62 62
Computer Operating System Problem 57 57
Delayed Program or Algorithm Execution 54 54
Activation, Positioning or Separation Problem 50 50
Excessive Heating 49 49
Insufficient Information 43 44
Mechanical Jam 41 41
Break 37 37
Improper or Incorrect Procedure or Method 36 36
Mechanics Altered 35 35
Naturally Worn 31 31
Patient Data Problem 31 31
Failure to Shut Off 30 30
Malposition of Device 26 26
Material Twisted/Bent 23 23
Data Problem 23 24
Positioning Problem 22 24
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 14335 14397
Unspecified Tissue Injury 225 226
Insufficient Information 153 155
Hemorrhage/Bleeding 99 99
Intracranial Hemorrhage 72 72
Unspecified Nervous System Problem 68 69
Cerebrospinal Fluid Leakage 66 67
Unspecified Infection 61 61
No Consequences Or Impact To Patient 48 48
Hematoma 38 38
Muscle Weakness 37 38
Pain 34 34
Dysphasia 32 32
Post Operative Wound Infection 28 28
Convulsion/Seizure 28 28
Paralysis 24 25
No Patient Involvement 20 20
Cognitive Changes 20 21
Nerve Damage 18 18
Paresis 18 19
Swelling/ Edema 18 18
Headache 17 17
Bacterial Infection 16 16
Foreign Body In Patient 16 16
Hydrocephalus 16 16
Ambulation Difficulties 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Numbness 15 16
Thrombosis/Thrombus 13 13
Paresthesia 13 14
Loss of Range of Motion 12 12
Bone Fracture(s) 12 12
Visual Impairment 11 11
Device Embedded In Tissue or Plaque 11 11
Memory Loss/Impairment 10 10
Meningitis 10 10
Perforation 9 9
Pleural Effusion 8 8
Brain Injury 8 8
Cardiac Arrest 8 8
Unintended Radiation Exposure 7 7
Abscess 7 7
Cancer 7 8
Spinal Column Injury 7 7
Confusion/ Disorientation 7 7
Visual Disturbances 6 6
Seroma 6 6
Fever 6 6
Urinary Tract Infection 6 6
Spinal Cord Injury 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 Apr-29-2026
5 Elekta, Inc. II Nov-05-2025
6 FHC, Inc. I Nov-08-2024
7 Globus Medical, Inc. II Feb-06-2024
8 Howmedica Osteonics Corp. II Dec-19-2025
9 MEDTECH SAS I Oct-25-2021
10 Medtronic Navigation, Inc. I May-09-2024
11 Medtronic Navigation, Inc. I Nov-10-2023
12 Medtronic Navigation, Inc. I Jun-02-2023
13 Medtronic Navigation, Inc. I Jun-02-2023
14 Medtronic Navigation, Inc. II Jan-30-2023
15 Medtronic Navigation, Inc. I Dec-22-2021
16 Medtronic Navigation, Inc. II Dec-22-2021
17 Medtronic Xomed, Inc. II Oct-21-2021
18 Navinetics Inc II Apr-04-2024
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