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