19 results · 21ms · Sources: EU EUDAMED, 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