8 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IntelAir Nasal Airway Support System
FDA 510(k)
FDA Class 2
·Anesthesiology
UTA AND UHA
FDA 510(k)
FDA Class 2
·Dental
LSO PET/CT HIREZ 64
FDA 510(k)
FDA Class 2
·Radiology
GYNECARE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTO·May 3, 2018
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 6, 2014
DIMENSION(R) CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code LCP·June 3, 2013
BD
FDA Adverse Event
Malfunction
·Product code FMF·June 22, 2011
PKG, PKG, HOOK SCISSORS, P/N 0250080260. 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