138 results · 27ms · Sources: EU EUDAMED, US FDA

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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