15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PRIMARY IV SET
FDA 510(k)
FDA Class 2
·General Hospital
EXT SET, PUR SMALLBORE BIFUSE W/2 CLAVE¿
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·October 3, 2025
SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM
FDA Adverse Event
Malfunction
·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020
SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM
FDA Adverse Event
Malfunction
·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020
SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM
FDA Adverse Event
Malfunction
·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020
SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM
FDA Adverse Event
Malfunction
·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020
SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM
FDA Adverse Event
Malfunction
·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020
UNSPECIFIED CENTRAL LINE CONNECTOR
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·July 8, 2025
94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non-DEHP Tubing
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·August 8, 2012
Edge™ Diamond PC014-4.5M Parallel Chamfer
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172005890·Diamond dental bur, reusable
VISION(TM) AMYLASE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VENTROFIL TENSION RELIEF SUTURE SET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SPRINT QUATTRO
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA·Product code LWS·February 15, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·January 19, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 29, 2014