22 results · 32ms · Sources: EU EUDAMED, US FDA

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Stowe Pedicle Screw System

FDA 510(k)
FDA Class 2 ·Orthopedic

Integra® Miltex®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780362227·McClure Iris Scissors 4-3/8", Angled on Flat, S...

Q-FLO CLOSED MALE LUER CONNECTOR

FDA 510(k)
FDA Class 2 ·General Hospital

TOKUYAMA TISSUECARE

FDA 510(k)
FDA Class 2 ·Dental

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 11, 2025

QUADRA-P FEMORAL STEMS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2025

OSSEOTITE® TAPERED CERTAIN® IMPLANT 3.25 X 15MM

FDA Adverse Event
Injury ·BIOMET 3I·Product code DZE·October 17, 2014

PALMAZ GENESIS 29MM BILIARY

FDA Adverse Event
Malfunction ·CORDIS CORPORATION·Product code FGE·June 21, 2013

9600

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 7, 2011

VERSAFITCUP DM DOUBLE MOBILITY HC LINER 50/28

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·May 17, 2021

CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 60

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 10, 2024

SUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS

FDA Adverse Event
Injury ·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GZL·June 14, 2019

LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMH

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·January 13, 2023

MPACT ACETABULAR SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 6, 2025

MECTACER BIOLOX DELTA FEMORAL BALL HEAD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 16, 2025

Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.

FDA Enforcement
Class II ·Terminated·Applied Medical Resources Corp·June 19, 2013

Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;

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

Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; 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

Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025