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TPLC
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show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
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Device
stimulator, bone growth, non-invasive
Product Code
LOF
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
4
1
9
2
3
7
7
8
5
10
8
3
2
7
5
2
MDR Year
MDR Reports
MDR Events
2014
3
3
2015
31
31
2016
48
48
2017
55
55
2018
36
36
2019
54
54
2020
142
142
2021
246
246
2022
158
158
2023
149
149
2024
32
32
Device Problems
MDRs with this Device Problem
Events in those MDRs
Patient-Device Incompatibility
481
481
Insufficient Information
330
330
Adverse Event Without Identified Device or Use Problem
303
303
Off-Label Use
27
27
Appropriate Term/Code Not Available
18
18
Biocompatibility
13
13
Overheating of Device
8
8
Device Operates Differently Than Expected
6
6
Inappropriate/Inadequate Shock/Stimulation
5
5
Patient Device Interaction Problem
5
5
Temperature Problem
4
4
Therapeutic or Diagnostic Output Failure
2
2
Output Problem
2
2
No Apparent Adverse Event
2
2
Unexpected Therapeutic Results
2
2
Component Incompatible
2
2
Device-Device Incompatibility
2
2
Device Dislodged or Dislocated
1
1
Inadequate Lighting
1
1
Power Conditioning Problem
1
1
Battery Problem
1
1
Fluid/Blood Leak
1
1
Loose or Intermittent Connection
1
1
Migration or Expulsion of Device
1
1
Nonstandard Device
1
1
Use of Device Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Defective Component
1
1
Sparking
1
1
Unintended Movement
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
420
420
Skin Inflammation/ Irritation
224
224
Rash
104
104
Skin Irritation
92
92
Itching Sensation
86
86
Blister
64
64
Burning Sensation
53
53
Hypersensitivity/Allergic reaction
40
40
Burn(s)
39
39
No Code Available
31
31
Swelling/ Edema
31
31
Unspecified Infection
27
27
Wheal(s)
26
26
Swelling
23
23
Cramp(s) /Muscle Spasm(s)
19
19
Headache
18
18
Shock
15
15
Numbness
14
14
Discomfort
12
12
Bruise/Contusion
11
11
Reaction
11
11
Erythema
10
10
Nausea
7
7
Inflammation
7
7
Lead(s), Burn(s) From
6
6
Ossification
6
6
Skin Discoloration
5
5
Muscle Spasm(s)
5
5
Skin Burning Sensation
5
5
Tissue Damage
5
5
Irritability
5
5
High Blood Pressure/ Hypertension
5
5
Skin Inflammation
5
5
Electric Shock
4
4
Pressure Sores
4
4
Post Traumatic Wound Infection
4
4
Abrasion
4
4
Neck Stiffness
3
3
Palpitations
3
3
Fatigue
3
3
No Known Impact Or Consequence To Patient
3
3
Complaint, Ill-Defined
3
3
Hair Loss
3
3
Urticaria
3
3
Chest Pain
3
3
Dizziness
3
3
Partial thickness (Second Degree) Burn
3
3
Shock from Patient Lead(s)
3
3
Neck Pain
3
3
Bacterial Infection
3
3
Unspecified Heart Problem
3
3
Irritation
3
3
Skin Tears
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Patient Problem/Medical Problem
2
2
Necrosis
2
2
Hemorrhage/Bleeding
2
2
Ambulation Difficulties
2
2
Insufficient Information
2
2
Fungal Infection
2
2
Staphylococcus Aureus
2
2
Scarring
2
2
Vomiting
2
2
Diarrhea
2
2
Nodule
2
2
Incontinence
2
2
Weakness
2
2
Superficial (First Degree) Burn
2
2
Contact Dermatitis
2
2
Failure of Implant
2
2
Vertigo
2
2
Skin Infection
2
2
Cellulitis
2
2
Vascular System (Circulation), Impaired
1
1
Constipation
1
1
Myalgia
1
1
Urinary Retention
1
1
Death
1
1
Abdominal Pain
1
1
Malunion of Bone
1
1
Hot Flashes/Flushes
1
1
Cyst(s)
1
1
Lymphoma
1
1
Loss of Range of Motion
1
1
Reaction to Medicinal Component of Device
1
1
Sensitivity of Teeth
1
1
Chills
1
1
Pulmonary Embolism
1
1
Convulsion/Seizure
1
1
Vitamin Deficiency
1
1
Increased Sensitivity
1
1
Arthritis
1
1
Ulcer
1
1
No Consequences Or Impact To Patient
1
1
Non specific EKG/ECG Changes
1
1
Sleep Dysfunction
1
1
Adhesion(s)
1
1
Sore Throat
1
1
Drug Resistant Bacterial Infection
1
1
Eye Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Bioventus, LLC
II
Jan-09-2021
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