13 results
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33ms
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Sources: EU EUDAMED, US FDA
SiO2 Coated syringe 3 ml
FDA 510(k)
FDA Class 2
·General Hospital
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100332·BARRAQUER INFANT WIRE SPECULUM
NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL
FDA 510(k)
FDA Class 2
·Immunology
LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION
FDA 510(k)
FDA Class 1
·Clinical Chemistry
QUADRA ASSURA CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·October 8, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 8, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 7, 2011
LUCAS 3 CHEST COMPRESSION SYSTEM
FDA Adverse Event
Death
·JOLIFE AB - 3005445717·Product code DRM·February 6, 2024
LUCAS 3 CHEST COMPRESSION SYSTEM
FDA Adverse Event
Death
·JOLIFE AB - 3005445717·Product code DRM·February 6, 2024
FUSION 8MM-40CM UNSUPP PERIPHERAL GRAFT
FDA Adverse Event
Malfunction
·MAQUET CV·Product code DSY·February 8, 2017
FUSION ENT NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·February 2, 2021
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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