10 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DEOX, OXYGEN BARRIER VISCOUS SOLUTION
FDA 510(k)
FDA Class 2
·Dental
MAS PCF
FDA UDI
Nuvasive, Inc.·00887517806284·MAS PCF Tube, Offset 5
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150737·K-WIRE - SINGLE TROCAR 1.0mm DIA x 150mm
PANALOK RC LOOP ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
CONSTELLATION VISION SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
N/A
FDA UDI
Zimmer, Inc.·00889024445079·
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·February 4, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·December 8, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 17, 2014
PKG, METZENBAUM SCISSORS, CURVED LONG, P/N 0250080265. 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