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