14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Koios DS
FDA 510(k)
FDA Class 2
·Radiology
MaXcess
FDA UDI
Nuvasive, Inc.·00887517198150·MaXcess 4 Blade, 130mm Right
Artman Instruments
FDA UDI
Wise Linkers, LLC·D1272421301·Dental Amalgam Filling Instruments Kit 7 Pieces...
NA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295122951·STERILIZATION TRAY UPPER
BD VACUTAINER® SERUM BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·February 20, 2020
ORAL BOND
FDA 510(k)
FDA Class 2
·Dental
AURA CPAP PATIENT INTERFACE
FDA 510(k)
FDA Class 2
·Anesthesiology
GLIDEWELL HT IMPLANT Ø3.5 X 11.5 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·October 15, 2025
GLIDEWELL HT IMPLANT Ø3.5 X 11.5 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·October 16, 2025
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 2, 2023
ADAPTER SLEEVES 12/14 +2
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·November 10, 2014
IPUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 23, 2013
PKG, GRASPER FORCEPS, NARROW JAW, P/N 0250080287. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014