42 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPINESMITH CYNCH SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950030521·MICRO IRIS SCISSOR STRAIGHT DELICATE FLAT 3-1/2...
Ultra-Pro II™ Needle Guide
FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436101971·Sterile needle guide with (14 x 91.5cm) CIV-Fle...
Mariner Deformity
FDA UDI
Seaspine Orthopedics Corporation·10889981256234·Tri-Flat Tap, 8.5mm
RIVA Pedicle Screw System
FDA UDI
XENIX MEDICAL LLC·00840493414546·Nav Awl-Tip Pedicle Tap, 8.5mm
AIRCARE Endotracheal Tube
FDA UDI
Well Lead Medical Co.,Ltd·00351688073375·Endotracheal Tubes without Cuff (Oral/Nasal)8.5
Zavation
FDA UDI
Zavation LLC·00197157009663·8.5mm TAP
GUIDEWIRE INTRODUCER SAFETY NEEDLE
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500
FDA 510(k)
FDA Class 2
·Cardiovascular
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 5, 2022
TAPERLC BMPC LAT 6.0X132 12/14
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code KWA·August 4, 2016
MAYFIELD MODIFIED SKULL CLAMP
FDA Adverse Event
Other
·INTEGRA-OHIO INC·Product code HBL·November 18, 2010
TAPERLOC PC 15.0 MM 12/14
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code KWA·August 4, 2016
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·May 9, 2013
NATURLAYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 3, 2014
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 24, 2011
TAPERLOC COMPLETE MICROPLASTY FEMORAL
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·January 20, 2017
TPRLC 133 TYPE1 BM SO 11.0
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·September 12, 2018
TAPERLOC BONEMASTER POROUS AND HYDROXYAPETITE COATED STEM
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code KWA·May 26, 2017
TAPERLOC TYPE1 BM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·December 4, 2018