13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TOTAL BILIRUBIN REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
artegral
FDA UDI
Merz Dental GmbH·D7091972073·posteriors; shade B3; size L; lower jaw
Hi-Torque Command 18 Guide Wire
FDA 510(k)
FDA Class 2
·Cardiovascular
VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
BD VACUTAINER PPT PLASMA PREPARATION TUBE K2E 9.0 MG
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·May 7, 2018
BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·April 26, 2018
BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·April 26, 2018
BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·April 26, 2018
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code KWA·February 21, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·January 27, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 31, 2014
BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·July 17, 2018
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026