2,936 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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JLAB
FDA UDI
JLab·00198168321867·
JLAB
FDA UDI
JLab·00198168796207·
JLAB
FDA UDI
JLab·00860014693915·
JLAB
FDA UDI
JLab·00860014693922·
SFXSPI MCL+ UNI UD 18IN 4-0 SA PS-2 PMP
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAM·June 11, 2025
SFXSPI MCL+ UNI UD 18IN 4-0 SA PS-2 PMP
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAM·June 11, 2025
NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
FDA Recall
Terminated
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JLH·May 10, 2021
Titrimetric, Fatty Acids
FDA classification
FDA Class 1
·Titrimetric, Fatty Acids
JLK, INC.
FDA registration
JLK, INC.·4 products·🇰🇷 South Korea
PrimeStore Molecular Transport Medium (PS-MTM), Model Numbers LH-1-2, LH-1-3, LH-1-4, LH-1-5, LH-1-5CC, LH-1-15CC - Product Usage: intended for stabilization, transportation, and inactivation of infectious unprocessed nasal washes, nasopharyngeal, oral/throat swabs* suspected of containing Influenza A virus RNA. PS-MTM is also intended for the stabilization, transportation, and inactivation of infectious unprocessed sputum samples suspected of containing Mycobacterium tuberculosis (MTB) DNA from human samples.
FDA Enforcement
Class II
·Ongoing·LONGHORN VACCINES AND DIAGNOSTIC·September 23, 2020
JKH Health Co., Ltd.
FDA registration
JKH Health Co., Ltd.·22 products·🇨🇳 China
PrimeStore Molecular Transport Medium (PS-MTM), Model Numbers LH-1-2, LH-1-3, LH-1-4, LH-1-5, LH-1-5CC, LH-1-15CC - Product Usage: intended for stabilization, transportation, and inactivation of infectious unprocessed nasal washes, nasopharyngeal, oral/throat swabs* suspected of containing Influenza A virus RNA. PS-MTM is also intended for the stabilization, transportation, and inactivation of infectious unprocessed sputum samples suspected of containing Mycobacterium tuberculosis (MTB) DNA from human samples.
FDA Recall
Open, Classified
·LONGHORN VACCINES AND DIAGNOSTIC 2 Bethesda Metro Cente·Product code QBD·June 3, 2020
ANHUI JBH MEDICAL APPARATUS CO., LTD
FDA registration
ANHUI JBH MEDICAL APPARATUS CO., LTD·5 products·🇨🇳 China
COULTER® LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·May 1, 2011
IMMULITE HLH
FDA 510(k)
FDA Class 1
·Clinical Chemistry
OPUS HLH
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Medibase Vent Tubes Bio
FDA UDI
J.H. Orsing AB·07393507382018·Aspirator tubes
Scantube Blue
FDA UDI
J.H. Orsing AB·07393507332112·Aspirator tubes
Eezivac Tubes
FDA UDI
J.H. Orsing AB·07393507392031·Aspirator tubes
Scantube Mint Green
FDA UDI
J.H. Orsing AB·07393507332068·Aspirator tubes