12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Zavation Posterior LEIF
FDA 510(k)
FDA Class 2
·Orthopedic
MICROFUSE PUTTY AND MICROFUSE ST MIS
FDA 510(k)
FDA Class 2
·Orthopedic
DAPTOMYCIN
FDA 510(k)
FDA Class 2
·Microbiology
RADIUS-7
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·July 2, 2015
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 5, 2014
PELVICOL ACELLULAR COLLAGEN MATRIX
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTL·May 8, 2013
RESPIRATORY GAS HUMIDIFIER- FOR USE WITH BREATHING GASES
FDA Adverse Event
Injury
·INVACARE·Product code BTT·June 21, 2011
ETEST DAPTOMYCIN DPC 256 WW S30
FDA Adverse Event
Malfunction
·BIOMÉRIEUX SA·Product code JWY·October 30, 2020
ETEST DAPTOMYCIN DPC 256 WW S30
FDA Adverse Event
Malfunction
·BIOMÉRIEUX SA·Product code JWY·October 30, 2020
PATIENT SAFETY NET
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code MSX·March 31, 2016
PATIENT SAFETY NET
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code MSX·March 31, 2016
PKG, 5MM X 45CM, INSERT, METZENBAUM CURVED SCISSORS, LONG JAW, P/N 0250080752 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