8 results
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17ms
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Sources: EU EUDAMED, US FDA
KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP
FDA 510(k)
FDA Class 2
·Radiology
Picosecond Nd:YAG Laser Systems (BL-C10)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LUMINA 24
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LIEFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·April 17, 2014
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·February 3, 2013
AKREOS MICRO INCISION LENS
FDA Adverse Event
Injury
·BAUSCH & LOMB, INC.·Product code HQL·December 20, 2010
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX 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
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020