27 results · 23ms · Sources: EU EUDAMED, US FDA

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InterActive Complete Surgical Tray

FDA 510(k)
FDA Class 2 ·General Hospital

PILLING

FDA UDI
TELEFLEX INCORPORATED·24026704508567·

LEONE SPA

FDA UDI
LEONE SPA·08033707011415·CALIBRA 1ST MOL BANDS W/G8025-02 n.UR 19

FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM MODEL FLX-DDLLL-BX

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

GAMMA-B 1,25-DIHYDROXY VITAMIN D

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

PRECISION XTRA

FDA Adverse Event
Malfunction ·Product code NBW·June 28, 2011

SOLYX SIS SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 3, 2013

ENCORE SYSTEM

FDA Adverse Event
Injury ·SIESTA MEDICAL INC.·Product code ORY·September 25, 2014

ELEVATE SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code MAX·July 8, 2020

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

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

FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

FDA Adverse Event
Injury ·COOK INC·Product code DYB·October 29, 2025

FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

FDA Adverse Event
Injury ·COOK INC·Product code DYB·October 29, 2025

FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·September 29, 2020

DYB INTRODUCER, CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code DYB·November 12, 2025

FLEXOR SHUTTLE SELECT GUIDING SHEATH

FDA Adverse Event
Injury ·COOK INC·Product code DYB·October 29, 2025

BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM

FDA Adverse Event
Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·April 25, 2019

FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·January 12, 2018

FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·April 19, 2021

UNKNOWN

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·September 15, 2020