157 results · 23ms · Sources: EU EUDAMED, US FDA

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Noddle(TM)

FDA 510(k)
FDA Class 2 ·Physical Medicine

Endo-Model SL Knee Prosthesis System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575370894·Tibial Component,modular, neutral

Endo-Model SL Knee Prosthesis System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575359219·Tibial Component,neutral

Endo-Model SL Knee Prosthesis System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575370887·Tibial Component,modular, neutral

Endo-Model SL Knee Prosthesis System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575359202·Tibial Component,neutral

Endo-Model SL Knee Prosthesis System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575359226·Tibial Component,neutral

Endo-Model SL Knee Prosthesis System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575370870·Tibial Component,modular, neutral

PTW DAVID IMRT QC VERIFICATION SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code ESW·September 3, 2021

Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm 16-2817/07 Tibial Component, Large, W: 75mm 16-2817/32 Tibial Component Modular, Small, W: 60mm 16-2817/35 Tibial Component Modular, Medium, W: 65mm 16-2817/37 Tibial Component Modular, Large, W: 75mm

FDA Enforcement
Class II ·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·July 24, 2024

EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code ESW·March 22, 2018

EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code ESW·December 19, 2024

EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code ESW·September 6, 2023

EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code ESW·August 15, 2022

EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code ESW·February 2, 2022

EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code ESW·October 3, 2019

Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm 16-2817/07 Tibial Component, Large, W: 75mm 16-2817/32 Tibial Component Modular, Small, W: 60mm 16-2817/35 Tibial Component Modular, Medium, W: 65mm 16-2817/37 Tibial Component Modular, Large, W: 75mm

FDA Recall
Open, Classified ·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code JWH·May 22, 2024

EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code ESW·August 11, 2022

EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code ESW·September 7, 2023