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