34 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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UNIMAX SPECIMEN RETRIEVAL SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SURE LOCK,A34,10 PK,GRN LEVER,CAREFUSION
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828149136·SURE LOCK,A34,10 PK,GRN LEVER,CAREFUSION
Atoll™
FDA UDI
Seaspine Orthopedics Corporation·10889981052102·3.5mm x 10mm Standard Screw. The Atoll OCT Spin...
Sochi
FDA UDI
Altus Spine, LLC·00843210166216·Standard Screw, 3.5mm x 10mm
Cortium Universal OCT Spinal Fixation System
FDA UDI
Ulrich Medical Usa, Inc.·00814386026338·Screw, Ø 3.5mm, length 10mm, high angulation
MINIMUM ESSENTIAL MEDIUM EAGLE NO. 210-3510
FDA 510(k)
FDA Class 1
·Hematology
POINT 4 MODIFIED
FDA 510(k)
FDA Class 2
·Dental
INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500
FDA 510(k)
FDA Class 2
·Radiology
EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code MQR·April 12, 2018
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code LOX·December 16, 2022
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 9, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·September 19, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 26, 2011
TREK¿
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code LOX·May 27, 2025
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code MQR·August 17, 2017
EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FAD·March 12, 2015
TREK¿
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code LOX·January 7, 2026
EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code MQR·March 15, 2018
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025