13 results
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29ms
·
Sources: EU EUDAMED, US FDA
Rusch Intermittent Urethral Catheters
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR
FDA 510(k)
FDA Class 2
·Radiology
NEOMED SINGLE LUMEN UMBILICAL CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM
FDA Adverse Event
Malfunction
·AESCULAP, INC.·Product code GEI·March 4, 2015
TRUWAVE, VAMP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·March 20, 2025
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·June 17, 2013
CNS-9700
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·September 10, 2014
VANGUARD DCM CR TIBIAL BEARING 10MM X 79/83MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·July 23, 2011
TRUWAVE, VAMP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code KRA·April 18, 2025
TRUWAVE, VAMP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·March 20, 2025
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code FCG·December 26, 2017
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025