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TPLC
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Device
source, brachytherapy, radionuclide
Product Code
KXK
Regulation Number
892.5730
Device Class
2
Premarket Reviews
Manufacturer
Decision
ADVANCED NUCLIDE TECHNOLOGIES, LLC
SUBSTANTIALLY EQUIVALENT
1
C.R. BARD, INC.
SUBSTANTIALLY EQUIVALENT
1
C4 IMAGING, LLC
SUBSTANTIALLY EQUIVALENT
1
CIVATECH ONCOLOGY INC.
SUBSTANTIALLY EQUIVALENT
1
CIVATECH ONCOLOGY, INC.
SUBSTANTIALLY EQUIVALENT
1
ECKERT & ZIEGLER BEBIG GMBH
SUBSTANTIALLY EQUIVALENT
1
GT MEDICAL TECHNOLOGIES
SUBSTANTIALLY EQUIVALENT
3
INTRAMEDICAL IMAGING, LLC
SUBSTANTIALLY EQUIVALENT
1
ISOAID, L.L.C.
SUBSTANTIALLY EQUIVALENT
1
ISORAY MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
ISORAY MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
LV LIBERTY VISION CORP.
SUBSTANTIALLY EQUIVALENT
1
LV LIBERTY VISION CORPORATION
SUBSTANTIALLY EQUIVALENT
1
RADIANCE THERAPEUTICS INC.
SUBSTANTIALLY EQUIVALENT
1
SALUTARIS MEDICAL DEVICES, INC.
SUBSTANTIALLY EQUIVALENT
2
SOURCE PRODUCTION & EQUIPMENT CO., INC.
SUBSTANTIALLY EQUIVALENT
1
SOURCE PRODUCTION AND EQUIPMENT CO., INC.
SUBSTANTIALLY EQUIVALENT
1
SOURCE PRODUCTION AND EQUIPMENT CO.,INC.
SUBSTANTIALLY EQUIVALENT
3
VARIAN MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
13
13
2015
6
6
2016
40
40
2017
41
41
2018
28
28
2019
10
10
2020
15
15
2021
62
62
2022
26
26
2023
9
9
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Physical Resistance/Sticking
59
59
Device Operates Differently Than Expected
18
18
Adverse Event Without Identified Device or Use Problem
17
17
Inadequate Instructions for Healthcare Professional
15
15
Sticking
15
15
Insufficient Information
12
12
Inaccurate Information
11
11
Migration or Expulsion of Device
11
11
Component Missing
10
10
Positioning Failure
9
9
Break
7
7
Mechanical Jam
6
6
Device Contamination with Chemical or Other Material
6
6
Device Markings/Labelling Problem
6
6
Appropriate Term/Code Not Available
6
6
Patient-Device Incompatibility
5
5
Incorrect Device Or Component Shipped
5
5
Device Inoperable
5
5
Fitting Problem
3
3
Component Falling
3
3
Labelling, Instructions for Use or Training Problem
3
3
Lack of Maintenance Documentation or Guidelines
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Material Integrity Problem
3
3
Output Problem
3
3
Defective Device
3
3
Device Dislodged or Dislocated
3
3
Radiation Overexposure
3
3
Missing Information
3
3
No Apparent Adverse Event
2
2
Data Problem
2
2
Activation, Positioning or Separation Problem
2
2
Tear, Rip or Hole in Device Packaging
2
2
Obstruction of Flow
2
2
Failure to Align
2
2
Packaging Problem
2
2
Material Twisted/Bent
2
2
Partial Blockage
2
2
Loose or Intermittent Connection
2
2
Incorrect Measurement
2
2
Failure to Discharge
2
2
Use of Device Problem
2
2
Improper or Incorrect Procedure or Method
1
1
Insufficient Flow or Under Infusion
1
1
Microbial Contamination of Device
1
1
Failure to Deliver
1
1
Inaccurate Delivery
1
1
Misassembled
1
1
Unintended Collision
1
1
Output above Specifications
1
1
Unsealed Device Packaging
1
1
Peeled/Delaminated
1
1
Loss of Power
1
1
Product Quality Problem
1
1
Difficult to Remove
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Entrapment of Device
1
1
Device Expiration Issue
1
1
Material Fragmentation
1
1
Hole In Material
1
1
Difficult to Insert
1
1
Computer Software Problem
1
1
Contamination
1
1
Radiation Leak
1
1
Accessory Incompatible
1
1
Air Leak
1
1
Mechanics Altered
1
1
Positioning Problem
1
1
Material Deformation
1
1
Installation-Related Problem
1
1
Human-Device Interface Problem
1
1
Inaccurate Dispensing
1
1
Inadequate Instructions for Non-Healthcare Professional
1
1
Failure to Advance
1
1
Expiration Date Error
1
1
Split
1
1
Date/Time-Related Software Problem
1
1
Computer Operating System Problem
1
1
Connection Problem
1
1
Contamination of Device Ingredient or Reagent
1
1
Detachment of Device or Device Component
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Device Packaging Compromised
1
1
Difficult to Open or Close
1
1
Patient Data Problem
1
1
Component Misassembled
1
1
Temperature Problem
1
1
Unclear Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
93
93
No Known Impact Or Consequence To Patient
68
68
No Consequences Or Impact To Patient
39
39
No Information
11
11
No Patient Involvement
10
10
No Code Available
9
9
Cancer
9
9
Ulcer
7
7
Fistula
7
7
Hemorrhage/Bleeding
7
7
Hematuria
6
6
Post Operative Wound Infection
6
6
Pain
5
5
Necrosis
4
4
Death
4
4
Foreign Body In Patient
4
4
Dysuria
3
3
Edema
3
3
Radiation Overdose
2
2
Radiation Burn
2
2
Incontinence
2
2
Inflammation
2
2
Urinary Retention
2
2
Stenosis
2
2
Injury
2
2
Patient Problem/Medical Problem
2
2
Radiation Exposure, Unintended
2
2
Not Applicable
2
2
Underdose
2
2
Cerebral Edema
2
2
Insufficient Information
2
2
Unintended Radiation Exposure
1
1
Urinary Incontinence
1
1
Ambulation Difficulties
1
1
Sleep Dysfunction
1
1
Ascites
1
1
Weight Changes
1
1
Bowel Perforation
1
1
Test Result
1
1
Vessel Or Plaque, Device Embedded In
1
1
Arthralgia
1
1
Reaction
1
1
Loss of consciousness
1
1
Irritability
1
1
Tooth Fracture
1
1
Therapeutic Response, Decreased
1
1
Toxicity
1
1
Radiation Underdose
1
1
Dizziness
1
1
Neurological Deficit/Dysfunction
1
1
Pleural Effusion
1
1
Rash
1
1
Scarring
1
1
Therapeutic Effects, Unexpected
1
1
Itching Sensation
1
1
Myocardial Infarction
1
1
Unspecified Infection
1
1
Diarrhea
1
1
Dyspnea
1
1
Hypersensitivity/Allergic reaction
1
1
Cardiac Arrest
1
1
Chest Pain
1
1
Emotional Changes
1
1
Fall
1
1
Fatigue
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Bard Brachytherapy, Inc.
II
Apr-27-2018
2
C.R. Bard, Inc.
II
Dec-20-2017
3
Source Production & Equipment Inc
II
Jun-25-2015
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