11 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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