10 results
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18ms
·
Sources: EU EUDAMED, US FDA
VIRECTOMY LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
Peerless Buccal Tube
FDA UDI
ORMCO CORPORATION·00889989022803·PEERLESS UPPER B/T -10X022X051 GING RT
EMERGE MEDICAL DISTAL RADIUS SET
FDA 510(k)
FDA Class 2
·Orthopedic
CYTO-CHEX BCT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HEMOCHRON SIGNATURE ELITE
FDA Adverse Event
Malfunction
·ACCRIVA DIAGNOSTICS·Product code JPA·May 25, 2016
NOT AVAILABLE
FDA Adverse Event
Malfunction
·RAYNER INTRAOCULAR LENSES LIMITED·Product code HQL·June 20, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 2, 2013
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·December 22, 2010
PKG, 5MM X 45CM, INSERT, METZENBAUM CURVED SCISSORS, LONG JAW, P/N 0250080752 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
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020