11 results · 38ms · Sources: EU EUDAMED, US FDA

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SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFAB

FDA 510(k)
FDA Class 1 ·General Hospital

VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES

FDA 510(k)
FDA Class 1 ·Ophthalmic

ARTHREX TWISTLOC SUTURE ANCHOR, MODEL AR-1924

FDA 510(k)
FDA Class 2 ·Orthopedic

LINEAR ST

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 7, 2020

EXPRO ELITE SNARE

FDA Adverse Event
Injury ·VASCULAR SOLUTIONS, INC·Product code MMX·June 19, 2017

OMNIGUIDE BEAMPATH FIBER AND ADAPTER

FDA Adverse Event
OMNIGUIDE, INC.·Product code GEX·October 19, 2010

LINEAR ST

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 11, 2021

DEXTRUS 4136

FDA Adverse Event
Injury ·BIOTRONIK SE & CO. KG·Product code NVN·April 22, 2013

CE INFUSOR LV 5, 12 PACK

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·April 27, 2011

COBAS MIRA PLUS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·July 7, 2008

CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024