1,006 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Multi Joint Handle
FDA UDI
Osstem Implant Co., Ltd.·08800000943886·
BARTELS ELISA LEGIONELLA URINIARY ANTIGEN
FDA Adverse Event
Malfunction
·TRINITY BIOTECH, USA·Product code MJH·November 10, 2021
BINAXNOW LEGIONELLA 22T (LFR)
FDA Adverse Event
Death
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MJH·February 8, 2023
ALERE BINAXNOW LEGIONELLA URINARY ANTIGEN TEST
FDA Adverse Event
Death
·ALERE SCARBOROUGH INC.·Product code MJH·March 1, 2019
BINAXNOW LEGIONELLA 22T (LFR)
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MJH·January 30, 2025
Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative detection of Legionella Pneumophila seragroup 1 antigen in human urine. Product Code: B1029-440
FDA Recall
Terminated
·Clark Laboratories, Inc.·Product code MJH·October 11, 2021
Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.
FDA Recall
Open, Classified
·Trinity Biotech USA·Product code MJH·July 22, 2025
NOW Legionella Urinary Antigen Test. 22 test kit. For In Vitro Diagnostic Use Product Code: 852-000
FDA Recall
Terminated
·Inverness Medical Professional Diagnostics·Product code MJH·September 29, 2006
Legionella, Spp., Elisa
FDA classification
FDA Class 2
·Legionella, Spp., Elisa
Blue Sky Bio, LLC.
FDA UDI
BLUE SKY BIO LLC·00815131023688·
CJH INC
FDA registration
CJH INC·1 product·🇺🇸 United States
MAH Freedom Appliance
FDA UDI
ALLESEE AOA-PRO·00889989038552·MAH Freedom Appliance
FUSSGOLD HANDELSGESELLSCHAFT MBH
FDA registration
FUSSGOLD HANDELSGESELLSCHAFT MBH·1 product·🇩🇪 Germany
MbH Fingertip Pulse Oximeter
FDA UDI
TAIDOC TECHNOLOGY CORPORATION·04717095034143·
BHM-Tech Produktionsgesellschaft mbH
FDA registration
BHM-Tech Produktionsgesellschaft mbH·1 product·🇦🇹 Austria
DAHLBERG HEARING AID MODEL MEH
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
MAH SING HEALTHCARE SDN BHD
FDA registration
MAH SING HEALTHCARE SDN BHD·4 products·🇲🇾 Malaysia
DENT A PHARM PRODUKTIONSGESELLSCHAFT MBH
FDA registration
DENT A PHARM PRODUKTIONSGESELLSCHAFT MBH·1 product·🇩🇪 Germany
CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000
FDA 510(k)
FDA Class 2
·Cardiovascular
Mixed Electrode Strip
FDA UDI
Ad-Tech Medical Instrument Corporation·00841823106773·