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TPLC
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Device
system, applicator, radionuclide, remote-controlled
Product Code
JAQ
Regulation Number
892.5700
Device Class
2
Premarket Reviews
Manufacturer
Decision
BEST MEDICAL INTERNATIONAL, INC.
SUBSTANTIALLY EQUIVALENT
1
BRAXX BIOTECH CO. LTD
SUBSTANTIALLY EQUIVALENT
1
C4 IMAGING LLC
SUBSTANTIALLY EQUIVALENT
1
ECKERT & ZIEGLER BEBIG GMBH
SUBSTANTIALLY EQUIVALENT
1
GC MEDTECH, LLC
SUBSTANTIALLY EQUIVALENT
2
GEOMED MEDIZIN-TECHNIK GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
1
KOBOLD, LLC
SUBSTANTIALLY EQUIVALENT
3
MICK RADIO-NUCLEAR INSTRUMENTS, INC.
SUBSTANTIALLY EQUIVALENT
4
NUCLETRON B.V.
SUBSTANTIALLY EQUIVALENT
4
NUCLETRON BV
SUBSTANTIALLY EQUIVALENT
3
SPENCER FILLMORE
SUBSTANTIALLY EQUIVALENT
1
VARIAN MEDICAL SYSTEMS INC.
SUBSTANTIALLY EQUIVALENT
2
VARIAN MEDICAL SYSTEMS, INC
SUBSTANTIALLY EQUIVALENT
9
VARIAN MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
17
MDR Year
MDR Reports
MDR Events
2014
18
18
2015
7
7
2016
3
3
2017
5
5
2018
2
2
2019
8
8
2020
8
8
2021
5
5
2022
5
5
2023
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
9
9
Adverse Event Without Identified Device or Use Problem
6
6
Material Integrity Problem
5
5
Use of Device Problem
5
5
Device Operates Differently Than Expected
5
5
Manufacturing, Packaging or Shipping Problem
5
5
Difficult to Remove
4
4
Computer Software Problem
3
3
Improper or Incorrect Procedure or Method
3
3
Insufficient Information
3
3
Device Disinfection Or Sterilization Issue
3
3
Material Twisted/Bent
2
2
Obstruction of Flow
2
2
Malposition of Device
2
2
Material Separation
2
2
Positioning Failure
2
2
Application Program Problem: Dose Calculation Error
2
2
Fluid/Blood Leak
2
2
Fracture
2
2
Difficult to Insert
1
1
Labelling, Instructions for Use or Training Problem
1
1
Leak/Splash
1
1
Misassembled
1
1
Product Quality Problem
1
1
Shipping Damage or Problem
1
1
Inadequacy of Device Shape and/or Size
1
1
Retraction Problem
1
1
Material Rupture
1
1
Crack
1
1
Deflation Problem
1
1
Burst Container or Vessel
1
1
Component or Accessory Incompatibility
1
1
Connection Problem
1
1
Loss of Data
1
1
Detachment of Device or Device Component
1
1
Material Deformation
1
1
Device Dislodged or Dislocated
1
1
Device Contaminated During Manufacture or Shipping
1
1
Expiration Date Error
1
1
Physical Resistance
1
1
Defective Device
1
1
Device Displays Incorrect Message
1
1
Material Perforation
1
1
Component Missing
1
1
Output below Specifications
1
1
Material Split, Cut or Torn
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
13
13
Foreign Body In Patient
9
9
No Information
9
9
No Clinical Signs, Symptoms or Conditions
7
7
No Code Available
4
4
Insufficient Information
4
4
No Patient Involvement
4
4
Radiation Underdose
4
4
Pain
3
3
Radiation Overdose
2
2
Hemorrhage/Bleeding
2
2
High Blood Pressure/ Hypertension
1
1
Unspecified Infection
1
1
Inflammation
1
1
Laceration(s)
1
1
Nausea
1
1
Necrosis
1
1
Oversedation
1
1
Dysphasia
1
1
No Consequences Or Impact To Patient
1
1
Discomfort
1
1
Injury
1
1
Numbness
1
1
Sleep Dysfunction
1
1
Underdose
1
1
Blood Loss
1
1
Abrasion
1
1
Exposure to Body Fluids
1
1
Radiation Burn
1
1
Erythema
1
1
Fatigue
1
1
Swelling
1
1
Weakness
1
1
Wound Dehiscence
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Device Embedded In Tissue or Plaque
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Nucletron BV
II
Jan-02-2020
2
Varian Medical Systems Inc
II
Jun-26-2015
3
Varian Medical Systems Inc
II
Jun-23-2015
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