17 results · 21ms · Sources: EU EUDAMED, US FDA

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ETHICON ABSORBABLE POLY (L-LACTIDE/GLYCOLIDE) SURGICAL SUTURE, UNDYED

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

NTE-2 THERMAL SENSITIVITY TESTER

FDA 510(k)
FDA Class 1 ·Neurology

FASHION FRAMES

FDA 510(k)
FDA Class 1 ·Ophthalmic

BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS

FDA Adverse Event
Malfunction ·SYNTHES BRANDYWINE·Product code FZX·September 21, 2015

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

E-POLY 36MM +3 MAXROM LNR SZ23

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code MAY·January 28, 2022

MINICAP

FDA Adverse Event
Death ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·February 15, 2013

LINE SET FOR AQUARIUS

FDA Adverse Event
Malfunction ·HAEMOTRONICS SPA·Product code FJK·January 19, 2011

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 29, 2014

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

BUTTRESS/COMPRESSION NUT FOR 357.369

FDA Adverse Event
Malfunction ·SYNTHES BRANDYWINE·Product code HST·September 21, 2015