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

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ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, PLASMA SCALPEL GS, TURBOVAC GS

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

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·H65810000740·Amalgam Carrier SE Steel #4

Custom Procedure Kit

FDA UDI
MEDIVATORS INC.·40677964000735·Custom Procedure Kit

NA

FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540469991·SHUNT PLACEMENT TOOL L 2-4

Preference 2

FDA UDI
SINTX Technologies, Inc.·M555244000074·Palm Handle

ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509

FDA 510(k)
FDA Class 2 ·Cardiovascular

BARCOMED 5MP1H

FDA 510(k)
FDA Class 2 ·Radiology

LEEP PRECISION GENERATOR

FDA Adverse Event
Malfunction ·COOPERSURGICAL, INC.·Product code HGI·November 13, 2020

ADVINCULA DELINEATOR UTERINE MANIPULATOR WITH 3.5 CM ULTEM KOH-EFFICIENT

FDA Adverse Event
Malfunction ·COOPERSURGICAL, INC.·Product code HEW·May 27, 2026

SMR CEMENTLESS FINNED STEM

FDA Adverse Event
Malfunction ·LIMACORPORATE S.P.A.·Product code HSD·February 6, 2023

T-FLEX ASPHERIC

FDA Adverse Event
Malfunction ·RAYNER INTRAOCULAR LENSES LTD.·Product code HQL·March 8, 2013

GOBED II

FDA Adverse Event
Malfunction ·STRYKER MEDICAL QUEBEC·Product code FNL·February 18, 2011

OXFORD PHASE III FEMORAL COMPONENT

FDA Adverse Event
Injury ·BIOMET, INC.·Product code HRY·February 18, 2008

IRISpec CA/ IRISpec CB Two-Part Urine Chemistry Control Twin Set, part no. 800-0074.

FDA Recall
Terminated ·International Remote Imaging Systems Inc·Product code JJW·April 29, 2005

LEEP PRECISION GENERATOR

FDA Adverse Event
Malfunction ·COOPERSURGICAL, INC.·Product code HGI·December 13, 2020

Precedence 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

SMALL POSTERIOR AUGMENT GLENOID PLATE, LEFT

FDA Adverse Event
Malfunction ·EXACTECH, INC.·Product code PHX·September 12, 2022

UNFOLDER PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·AMO PUERTO RICO MFG. INC.·Product code KYB·January 8, 2025

UNFOLDER PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·AMO PUERTO RICO MFG. INC.·Product code KYB·January 8, 2025

UNFOLDER PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·AMO PUERTO RICO MFG. INC.·Product code KYB·January 8, 2025