16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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