140 results · 24ms · Sources: EU EUDAMED, US FDA

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Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel

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

IND URINARY TRACT INFECTION (UTI) TEST STRIPS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

PAIN-AID

FDA 510(k)
FDA Class 2 ·Neurology

STEM EXTENSION

FDA Adverse Event
Injury ·ZIMMER MANUFACTURING B.V.·Product code JWH·March 29, 2023

STEMMED NONAUGMENTABLE TIBIAL COMPONENT

FDA Adverse Event
Injury ·ZIMMER MANUFACTURING B.V.·Product code JWH·June 9, 2023

LCCK NEXGEN ARTICULAR SURFACE WITH LOCKING SCREW

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·February 9, 2022

ORTHO SUMMIT SAMPLE HANDLING SYSTEM

FDA Adverse Event
Malfunction ·HAMILTON BONADUZ AG·Product code MMH·July 23, 2011

2520274-2013-03441

FDA Adverse Event
Injury ·SYNTHES USA·Product code HSB·June 17, 2013

9600EMI

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 19, 2008

ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code FGE·December 13, 2024

Disposable Accessory Kit, 3-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]

FDA Enforcement
Class II ·Terminated·Ecolab Inc·October 31, 2018

ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code FGE·October 24, 2024

ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code FGE·October 17, 2023

ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code GBO·October 11, 2021

ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code FGE·July 1, 2024

ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code FGE·July 5, 2024

RHYTHMIA HDX

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·October 16, 2025

ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code FGE·August 6, 2020

ULTRATHANE BILIARY DRAINAGE CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code GBO·August 11, 2020

ULTRATHANE BILIARY DRAINAGE CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code GBO·August 11, 2020