9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COMFIT EXAMINATION GLOVES, POWDER FREE, HYPOALLERGENIC
FDA 510(k)
FDA Class 1
·General Hospital
PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003
FDA 510(k)
FDA Class 2
·Orthopedic
FreedomFlow Orbital Circumferential Atherectomy System
FDA 510(k)
FDA Class 2
·Cardiovascular
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·July 27, 2015
4.0MM CANCELLOUS BONE SCREW FULLY THREADED/24MM
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HWC·February 5, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 17, 2014
ONYX
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·August 3, 2023
PKG, AXIAL HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080235. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.
FDA Enforcement
Class II
·Ongoing·Biointellisense Inc.·August 21, 2024