15 results · 21ms · Sources: EU EUDAMED, 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