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

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OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS

FDA 510(k)
FDA Class 2 ·Orthopedic

CAINA

FDA UDI
Jiangsu Caina Medical Co.,Ltd·06971564465076·Syringe with safety needle 1ml 23Gx1.The Syring...

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K1230010·Rod Holder, Straight, 5.5 mm

ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES

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

GOLD CORE 35

FDA 510(k)
FDA Class 2 ·Dental

ONYX AVM

FDA Adverse Event
Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·August 13, 2025

EON

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 17, 2013

530G INSULIN PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OZO·September 26, 2014

PRECISION®

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 14, 2011

BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH DUAL PORT

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 17, 2018

KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size 2 / Infant Silicone King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway

FDA Enforcement
Class II ·Terminated·King Systems Corp.·November 28, 2012

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

Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.

FDA Enforcement
Class II ·Terminated·Integra LifeSciences Corp.·February 26, 2014