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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
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 9
CLARONAV
  SUBSTANTIALLY EQUIVALENT 1
CLEARPOINT NEURO INC.
  SUBSTANTIALLY EQUIVALENT 5
CLEARPOINT NEURO, INC.
  SUBSTANTIALLY EQUIVALENT 5
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
INTRAVENT MEDICAL PARTNERS, LP
  SUBSTANTIALLY EQUIVALENT 1
KOH YOUNG TECHNOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 1
LOCALITE GMBH
  SUBSTANTIALLY EQUIVALENT 1
MEDTECH S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDTECH S.A.S
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC NAVIGATION
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NAVIGATION INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NAVIGATION, INC.
  SUBSTANTIALLY EQUIVALENT 3
MRI INTERVENTIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
NAVINETICS INC.
  SUBSTANTIALLY EQUIVALENT 1
NAVINETICS, INC
  SUBSTANTIALLY EQUIVALENT 1
PAJUNK GMBH MEDIZINTECHNOLOGIE
  SUBSTANTIALLY EQUIVALENT 2
SINOVATION (BEIJING) MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SOTERIX MEDICAL, INC.
  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 1
ZETA SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 3480 3480
2021 2827 2827
2022 1930 1930
2023 2515 2515
2024 3758 3758
2025 1276 1276

Device Problems MDRs with this Device Problem Events in those MDRs
Application Program Freezes, Becomes Nonfunctional 2899 2899
Device Sensing Problem 2104 2104
Imprecision 1861 1861
Application Program Problem 1687 1687
Mechanical Problem 1671 1671
Display or Visual Feedback Problem 1241 1241
Material Integrity Problem 1116 1116
Communication or Transmission Problem 1098 1098
Human-Device Interface Problem 958 958
Incorrect, Inadequate or Imprecise Result or Readings 937 937
Environmental Compatibility Problem 890 890
Adverse Event Without Identified Device or Use Problem 778 778
Use of Device Problem 608 608
Connection Problem 588 588
Computer Software Problem 334 334
Unexpected Shutdown 304 304
Output Problem 170 170
Incorrect Measurement 161 161
Electrical /Electronic Property Problem 138 138
Unintended Application Program Shut Down 128 128
Power Problem 95 95
Mechanical Jam 85 85
Fracture 79 79
Computer Operating System Problem 74 74
Failure to Power Up 67 67
Material Fragmentation 55 55
Break 54 54
No Device Output 53 53
Improper or Incorrect Procedure or Method 52 52
Insufficient Information 52 52
Patient Data Problem 51 51
Mechanics Altered 47 47
Excessive Heating 40 40
Failure to Read Input Signal 40 40
Unintended Collision 38 38
Delayed Program or Algorithm Execution 36 36
Malposition of Device 34 34
Data Problem 32 32
Material Twisted/Bent 32 32
Activation, Positioning or Separation Problem 32 32
Failure to Shut Off 26 26
Image Display Error/Artifact 23 23
Deformation Due to Compressive Stress 22 22
Unintended Movement 19 19
Material Deformation 19 19
Naturally Worn 18 18
Device-Device Incompatibility 18 18
Audible Prompt/Feedback Problem 17 17
Positioning Problem 16 16
Detachment of Device or Device Component 15 15

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12456 12456
No Patient Involvement 1449 1449
No Known Impact Or Consequence To Patient 1233 1233
No Consequences Or Impact To Patient 293 293
Unspecified Tissue Injury 216 216
Insufficient Information 125 125
Hemorrhage/Bleeding 99 99
Cerebrospinal Fluid Leakage 69 69
Unspecified Infection 63 63
Intracranial Hemorrhage 61 61
No Code Available 60 60
Unspecified Nervous System Problem 54 54
Tissue Damage 53 53
Pain 34 34
Hematoma 34 34
Muscle Weakness 32 32
Post Operative Wound Infection 31 31
Dysphasia 30 30
Convulsion/Seizure 24 24
Paralysis 21 21
Nerve Damage 18 18
Device Embedded In Tissue or Plaque 18 18
Cognitive Changes 16 16
Bacterial Infection 15 15
Paresis 15 15
Foreign Body In Patient 14 14
Swelling/ Edema 14 14
Bone Fracture(s) 14 14
Thrombosis/Thrombus 13 13
Headache 13 13
Paresthesia 13 13
Hydrocephalus 12 12
Loss of Range of Motion 12 12
Numbness 12 12
Meningitis 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Visual Impairment 10 10
No Information 9 9
Perforation 9 9
Ambulation Difficulties 9 9
Brain Injury 8 8
Cardiac Arrest 8 8
Pleural Effusion 8 8
Abscess 8 8
Spinal Column Injury 7 7
Confusion/ Disorientation 7 7
Urinary Tract Infection 7 7
Unintended Radiation Exposure 7 7
Dysphagia/ Odynophagia 6 6
Memory Loss/Impairment 6 6

Recalls
Manufacturer Recall Class Date Posted
1 Brainlab AG II Oct-06-2020
2 Elekta Inc II Apr-29-2020
3 Elekta Instrument AB I Nov-06-2024
4 Elekta Instrument AB I Apr-16-2024
5 Elekta Instrument AB II Mar-30-2023
6 Elekta Instrument AB II Jul-10-2020
7 FHC, Inc. I Nov-08-2024
8 Globus Medical, Inc. II Feb-06-2024
9 MEDTECH SAS I Oct-25-2021
10 MEDTECH SAS II Feb-11-2020
11 Medtronic Navigation, Inc. I May-09-2024
12 Medtronic Navigation, Inc. I Nov-10-2023
13 Medtronic Navigation, Inc. I Jun-02-2023
14 Medtronic Navigation, Inc. I Jun-02-2023
15 Medtronic Navigation, Inc. II Jan-30-2023
16 Medtronic Navigation, Inc. I Dec-22-2021
17 Medtronic Navigation, Inc. II Dec-22-2021
18 Medtronic Navigation, Inc. II Jul-27-2020
19 Medtronic Navigation, Inc. I May-18-2020
20 Medtronic Xomed, Inc. II Oct-21-2021
21 Navinetics Inc II Apr-04-2024
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