29 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WET CHAMBER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Safco DENTA-SAFE NON-LATEX DENTAL DAM
FDA UDI
SAFCO DENTAL SUPPLY CO.·10810063750166·Heavy (0.23mm-0.28mm thickness) 6" x 6", green,...
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120207811·Carbide - Excavating and fissure burs
DIRECT TIBC KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MEDICAL CABLES PATIENT MONITORING CABLES FOR ECG, EEG, SPO2, AND BLOOD PRESSURE MONITORS
FDA 510(k)
FDA Class 2
·Cardiovascular
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·December 17, 2018
ZILVER BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·March 5, 2020
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·September 26, 2018
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·August 24, 2018
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·August 24, 2018
MEDICAL COMPRESSOR
FDA Adverse Event
Malfunction
·EKOM SPOL. S.R.O.·Product code BTI·April 5, 2011
AMICI SWIRLER WITH MOUTHPIECE
FDA Adverse Event
Malfunction
·AMICI INC·Product code CAF·March 21, 2013
FREESTYLE FREEDOM LITE
FDA Adverse Event
Malfunction
·Product code NBW·March 16, 2011
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
FDA Adverse Event
Malfunction
·HAMILTON BONADUZ AG·Product code JTC·March 17, 2008
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code FOZ·April 1, 2025
Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·October 11, 2017
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·October 11, 2017
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·October 11, 2017
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code FOZ·August 11, 2025