19 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Coloring Liquid
FDA 510(k)
FDA Class 2
·Dental
LEONE SPA
FDA UDI
LEONE SPA·08033707022114·CALIBRA BANDS 2ND MOLAR n.SUR 17
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551122838·HALO, 1220-5 VEST SMALL, ACRYLIC LINER, 1211-1 ...
Symmetry Ribbon
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482045664·Symmetry® Retractor, Ribbon, Malleable, 5/8 in ...
TriVerse IM Rod
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215108915·
FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDX 1000 SERIES
FDA 510(k)
FDA Class 2
·Physical Medicine
FLEXISION
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code EOQ·March 21, 2023
FLEXISION BIOPSY NEEDLE, 21G
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code EOQ·February 1, 2023
BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·May 2, 2018
SPECTRUM IQ INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·March 23, 2022
SPECTRUM IQ INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·June 13, 2022
SPECTRUM IQ INFUSION PUMP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code FRN·May 25, 2022
LINOX SMART SD 65/16
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVY·July 13, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·November 3, 2014
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013
SPECTRUM IQ INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·June 16, 2022
OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It measures these necessary values successively through a non-contact optical measurement method.
FDA Enforcement
Class II
·Terminated·Nidek Inc·August 24, 2016
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 19, 2023