13 results · 29ms · Sources: EU EUDAMED, US FDA

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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