24 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE
FDA 510(k)
FDA Class 2
·Anesthesiology
RESPIRONICS
FDA Adverse Event
Malfunction
·Product code MNT·April 8, 2021
Restore Interbody Fusion
FDA UDI
Republic Spine, LLC·B075110083010·Lumbar Tamp
Leva® Anterior Interbody System
FDA UDI
Spine Wave, Inc.·10840642109023·Modular Spacer, 38 mm (W) x 30 mm (L) x 9 mm (H...
Restore Interbody Fusion
FDA UDI
Republic Spine, LLC·B075110083020·Lumbar Tamp - Long
7D Surgical Drill Guide (Short)
FDA UDI
7D Surgical ULC·00628341520737·
STILLE Osteotomes
FDA UDI
Stille AB·07332339232931·HAND OSTEOTOME STILLE 8 mm curved blade R45 mm ...
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1100530·Caddie, 7.5mm Screws
Avalign
FDA UDI
Avalign Technologies, Inc.·00190776021382·Pass Thru Bracket
TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A
FDA 510(k)
FDA Class 2
·Cardiovascular
ESTHETICA
FDA 510(k)
FDA Class 2
·Dental
INDIGO SYSTEM ASPIRATION CATHETER 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·August 3, 2022
INDIGO SYSTEM ASPIRATION CATHETER 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·August 20, 2022
PINNACLE MTL INS NEUT40IDX56OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 13, 2013
TRIMA ACCEL PLT, PLS, RBC SET
FDA Adverse Event
Other
·CARIDIANBCT·Product code LKN·May 20, 2011
GE OEC 9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·August 14, 2008
INDIGO SYSTEM SEPARATOR 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·September 13, 2022
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code OVD·December 18, 2019
INDIGO SYSTEM ASPIRATION CATHETER 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·October 13, 2023
SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352R1
FDA Enforcement
Class II
·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022