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

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Love Liquid Personal Lubricant

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

K152468

FDA UDI
Shenzhen Vistar Medical Supplies Co.,Ltd.·96973521874184·Reusable NIBP cuff,Thigh,single tube, HP connector

Simpact Tri-Fin

FDA UDI
Life Spine, Inc.·00190837063061·300mm x 2.4mm Steinmann Pin, Blunt-Blunt, 17-4 SS

SENSEI X ROBOTIC CATHETER SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC.

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

QC F/K-WIRES Ø0.6-3.2 F/COMPACT AIR DRIV

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HWE·October 8, 2014

PELVITEX POLYPROPYLENE MESH

FDA Adverse Event
Injury ·SOFRADIM PRODUCTION·Product code FTL·May 24, 2013

CURETTE, SPINAL (COBB)

FDA Adverse Event
Malfunction ·CODMAN & SHURTLEFF, INC.·Product code FZS·June 23, 2011

ALINITY C PROCESSING MODULE

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code JJE·March 21, 2024

EVOLUT FX VALVE

FDA Adverse Event
Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 22, 2024

ROSA ONE

FDA Adverse Event
Malfunction ·MEDTECH SA·Product code HAW·September 24, 2020

ProScreen 10 Panel Cup, Item No. PSCup-10M

FDA Enforcement
Class III ·Terminated·Ameditech Inc·December 30, 2015

Allura Xper FD20/20; System Code: 722038;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·April 9, 2014

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023