138 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VARIAX 2 COMPRESSION PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MIRABAY
FDA UDI
Mirabay Orthodontics Corp.·05065025111617·KLEOS 2 PSL METAL STANDARD TORQUE 022 LL12-LR12...
Aztec
FDA UDI
Aztecmed/Ent LLC·B87111300090·Rhinus Blakesley Forcep Straight
OsteoMed
FDA UDI
OSTEOMED LLC·00845694002950·11mm Left ZED Plate
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193112992·HA PEEK EVOS Straight, ,9mmx10mmx 30mm , FLAT 5...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694063890·1.6 System 11mm Left Z Plate Sterile Qty 2
KSEA POWERSHAVER SYSTEM S2
FDA 510(k)
FDA Class 2
·Orthopedic
SENTICARE PILLSTATION
FDA 510(k)
FDA Class 1
·Physical Medicine
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 26, 2025
INSPIRE 7F M N/S
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·December 29, 2025
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 24, 2013
CAROTID WALLSTENT MONORAIL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIM·June 16, 2011
EXTENDED TIP APPLICATOR BOX OF 5
FDA Adverse Event
Malfunction
·CONFLUENT·Product code FMF·August 19, 2008
INSPIRE 7F M N/S
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA - S.R.L.·Product code DTZ·February 19, 2026
Universal Nerve Block Tray Catalog Number: 9779
FDA Enforcement
Class II
·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·EDWARDS EXPANDABLE INTRODUCER SHEATH SET
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Edwards Sapien XT Transcatheter Heart Valve
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Edwards Sapien XT Transcatheter Heart Valve
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Edwards SAPIEN XT Transcatheter Heart Valve