9 results · 27ms · Sources: EU EUDAMED, US FDA

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ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903

FDA 510(k)
FDA Class 2 ·Cardiovascular

EBI SYNERGY SPINE SYSTEM

FDA Adverse Event
Malfunction ·EBI, L.P.·Product code MNH·January 3, 2007

SILEX SACROILIAC JOINT FUSION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

M.L. PRIMER

FDA 510(k)
FDA Class 2 ·Dental

HQL - INTRAOCULAR LENS

FDA Adverse Event
Injury ·RAYNER INTRAOCULAR LENSES LIMITED·Product code HQL·June 20, 2014

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·February 1, 2013

CONSTELLATION WITH LASER

FDA Adverse Event
Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·December 22, 2010

PKG, GRASPER FORCEPS, SERRATED, P/N 0250080286. 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