12 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FDA 510(k)
FDA Class 2
·General Hospital
Prime Medical LLC
FDA UDI
Prime Medical LLC·00850055249295·PrimePadPlus-K15-3422
KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
MIS ANTERIOR CERVICAL PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LIMITORR VOLUME LIMITING EVD 30 ML
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES PR·Product code JXG·February 5, 2019
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·July 7, 2011
CAPD DISCONNECT Y SET
FDA Adverse Event
Death
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 8, 2013
JOURNEY
FDA Adverse Event
Malfunction
·SMITH & NEPHEW, INC.·Product code HWA·July 11, 2008
FUSION 8MM-40CM UNSUPP PERIPHERAL GRAFT
FDA Adverse Event
Malfunction
·MAQUET CV·Product code DSY·February 8, 2017
ASAHI CONQUEST PRO 9-40
FDA Adverse Event
Malfunction
·ASAHI INTECC CO., LTD.·Product code DQX·April 27, 2016
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