10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TECNADYNE 20/20 FOG INHIBITOR KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
XLIF
FDA UDI
Nuvasive, Inc.·00887517452788·XLIF Pituitary, Large
3M™ ESPE™
FDA UDI
3M COMPANY·30605861030954·3M™ ESPE™ Gold Anodized Crown Refills, Second M...
PEDILOC FRAGMENT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2
FDA 510(k)
FDA Class 2
·Immunology
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·April 17, 2014
BHR
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·February 4, 2013
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·December 17, 2010
PKG, FIXATION CLAMP 5MM WITH RATCHET, P/N 0250080130 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