350 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033650·Baltic Denture System BDLoad BDLoad Mw7 PLSEbi...
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MET1000, MOR2000, THC, X
FDA UDI
ALFA SCIENTIFIC DESIGNS, INC.·10796918001136·INSTANT-VIEW Multi-Drugs of Abuse Urine Test AM...
PERMLASTIC 3
FDA 510(k)
FDA Class 2
·Dental
ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD
FDA 510(k)
FDA Class 2
·Dental
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 3, 2013
CIC PRO CLINICAL INFORMATION CENTER
FDA Adverse Event
Malfunction
·GE HEALTHCARE·Product code DSI·February 11, 2011
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·August 25, 2014
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 15, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 8, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 5, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 5, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 15, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 19, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 19, 2026
Advia Chemistry Calibrator For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the following methods: Albumin (ALB, ALB_c), Direct Bilirubin (DBIL_2), Total Bilirubin (TBIL_2), Calcium (CA, CA_c, CA_2, CA_2c), Cholesterol (CHOL), Creatinine (CREA, CREA_2, CRE_2c, ECRE_2), Glucose Hexakinase (GLUH), Glucose Oxidase (GLUO), Iron (IRON_2), Lithium (LITH), Magnesium (MG, MG_c), Phosphorus - inorganic (IP, IP_c), Total Protein (TP, TP_c), Triglycerides (TRIG), Urea Nitrogen (UN, UN_c), Uric Acid (UA, UA_c)
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·November 23, 2016
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 20, 2026
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·September 9, 2025
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·September 9, 2025
BD PHOENIX¿ NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·September 9, 2025