11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FLYNNR GENESIS II A/C, A/O AND IDLH
FDA 510(k)
FDA Class 2
·Anesthesiology
Reef TH
FDA UDI
Seaspine Orthopedics Corporation·10889981202675·Interbody, 9mm x 32mm x 17mm, 0 deg
Reef TA
FDA UDI
Seaspine Orthopedics Corporation·10889981194680·Interbody, 9mm x 32mm x 17mm, 0 deg
TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000
FDA 510(k)
FDA Class 2
·Anesthesiology
SHASER V-MINI RX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENDO GIA ADAPTER STANDARD
FDA Adverse Event
Malfunction
·COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES·Product code GDW·April 3, 2014
UNKNOWN STRATA VALVE/SHUNT
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·January 25, 2013
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
FDA Adverse Event
Malfunction
·STAAR SURGICAL CO.·Product code HQL·December 8, 2010
ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) (GREEN) IH-CARD AHG ANTI-IGG
FDA Adverse Event
Malfunction
·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code QHS·February 1, 2021
ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) (GREEN) IH-CARD AHG ANTI-IGG
FDA Adverse Event
Malfunction
·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code QHS·February 1, 2021
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·May 16, 2018