System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy

Product Code: MEQ

Microwave Hyperthermia Therapy Devices

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations:


Radiation TypeMicrowave EMF
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as MEQ

2206System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy

Total Product Life Cycle (TPLC) Devices

2206System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy

Pre-market Approvals for MEQ

P950014PROSTATRONUrologix, Inc.
P010055PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOTHERAPY FOR BPHPROSTALUND AB
P970008UROLOGIX TARGIS SYSTEMUrologix, LLC
P030006Prolieve Thermodilation SystemMEDIFOCUS, INC

Global Unique Device Identification Database

07350081910082System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
07350081910075System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
07350081910068System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
07350081910051System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
07350081910044System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
07350081910037System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
07350081910020System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
07350081910013System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

Maude Adverse Events

COOLWAVEUROLOGIX, LLC2018-12-26
AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPYAMERICAN MEDICAL SYSTEMS (MN)2015-08-11
TARGIS SYSTEMUROLOGIX, INC.2015-01-20
AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPYAMERICAN MEDICAL SYSTEMS (MN)2014-11-10
AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPYAMERICAN MEDICAL SYSTEMS (MN)2014-11-10
AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPYAMERICAN MEDICAL SYSTEMS (MN)2014-11-10
AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPYAMERICAN MEDICAL SYSTEMS (MN)2014-11-10
AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPYAMERICAN MEDICAL SYSTEMS (MN)2014-11-10
AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPYAMERICAN MEDICAL SYSTEMS (MN)2014-11-10
AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPYAMERICAN MEDICAL SYSTEMS (MN)2014-11-10
AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPYAMERICAN MEDICAL SYSTEMS (MN)2014-11-10
AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPYAMERICAN MEDICAL SYSTEMS (MN)2014-11-10
AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPYAMERICAN MEDICAL SYSTEMS (MN)2014-11-10
AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPYAMERICAN MEDICAL SYSTEMS (MN)2014-11-10
AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPYAMERICAN MEDICAL SYSTEMS (MN)2014-11-10
AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPYAMERICAN MEDICAL SYSTEMS (MN)2014-11-10
AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPYAMERICAN MEDICAL SYSTEMS (MN)2014-11-10
AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPYAMERICAN MEDICAL SYSTEMS (MN)2014-11-06
AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPYAMERICAN MEDICAL SYSTEMS (MN)2014-10-22
AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPYAMERICAN MEDICAL SYSTEMS (MN)2014-10-22
PROLIEVE2014-10-12
TARGIS SYSTEMUROLOGIX, INC.2014-06-30
AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPYAMERICAN MEDICAL SYSTEMS (MN)2014-06-20
TARGIS SYSTEMUROLOGIX, INC2014-05-12
TARGIS SYSTEMUROLOGIX, INC2014-02-18
TARGIS SYSTEMUROLOGIX, INC.2013-07-24
TARGIS SYSTEMUROLOGIX, INC.2013-05-16
THERMATRXAMERICAN MEDICAL SYSTEMS, INC.2013-04-23
TARGIS SYSTEMUROLOGIX, INC2013-03-12
THERMATRX CATHETERAMERICAN MEDICAL SYSTEMS, INC.2013-02-26
THERMATRX CATHETERAMERICAN MEDICAL SYSTEMS, INC.2013-02-07
THERMATRX THERMO THERAPYAMERICAN MEDICAL SYSTEMS, INC.2013-01-08
CDEMBRACE LIFE PROSTATE WITHOUT ENLARGEDUROLOGIX, INC.2012-12-08
TARGIS SYSTEMUROLOGIX, INC.2012-11-29
TARGIS SYSTEMUROLOGIX, INC.2012-10-10
THERMATRXAMERICAN MEDICAL SYSTEMS, INC.2012-09-07
PROLIEVE THERMODILITATION SYSTEMBOSTON SCIENTIFIC - MARLBOROUGH2012-07-13
TARGIS SYSTEMUROLOGIX, INC.2012-07-10
TARGIS SYSTEMUROLOGIX, INC2012-07-06
TARGIS SYSTEMUROLOGIX, INC.2012-06-25
TARGIS SYSTEMUROLOGIX, INC.2012-06-20
TARGIS SYSTEMUROLOGIX, INC.2012-06-20
TARGIS SYSTEMUROLOGIX, INC.2012-04-06
PROLIEVE THERMODILITATION SYSTEMBOSTON SCIENTIFIC - MARLBOROUGH2012-03-05
PROLIEVE THERMODILITATION SYSTEMBOSTON SCIENTIFIC - MARLBOROUGH2012-03-01
THERMATRXAMERICAN MEDICAL SYSTEMS, INC.2012-02-22
THERMATRXAMERICAN MEDICAL SYSTEMS, INC.2012-02-22
TARGISUROLOGIX2012-02-01
PROLIEVE THERMODILITATION SYSTEMBOSTON SCIENTIFIC - MARLBOROUGH2011-12-14
PROLIEVE THERMODILITATION SYSTEMBOSTON SCIENTIFIC - MARLBOROUGH2011-12-14

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