38 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY
FDA 510(k)
FDA Class 2
·Radiology
Altus Spine Cervical Interbody Fusion System
FDA UDI
Altus Spine, LLC·00843210131054·ALR Sizer W/Tab
n/a
FDA UDI
Ortho Development Corporation·00822409088959·Modular Stem Inserter Threaded
Zavation
FDA UDI
Zavation LLC·00842166182110·Double Set Screw Inserter
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193107929·HA PEEK EVOS Straight, ,8mmx8mmx 26mm , FLAT 0...
Cutimed® Sorbion®
FDA UDI
BSN medical GmbH·04042809703184·CUTIMED SORBION BORDER SACRUM STERILE 19.5X22CM 10
OsteoMed
FDA UDI
OSTEOMED LLC·00845694054713·PrimaLIF Tissue Shim
CARDO MEDICAL CERAMIC HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921
FDA 510(k)
FDA Class 2
·General Hospital
ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025
BD NEEDLE ECLIPSE SMARTSLIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·January 16, 2025
GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DYB·February 21, 2018
OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
FDA Recall
Terminated
·OrthoPediatrics Corp·Product code MBI·June 5, 2020
OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
FDA Recall
Terminated
·OrthoPediatrics Corp·Product code MBI·June 5, 2020
ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 8, 2013
GRANUFLO
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
BD LUER-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·January 17, 2025
OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
FDA Enforcement
Class II
·Terminated·OrthoPediatrics Corp·July 15, 2020