18 results · 19ms · Sources: EU EUDAMED, US FDA

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CLEANING SOLUTION, CATALOG NO. 8203

FDA 510(k)
FDA Class 1 ·General Hospital

POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

CRE Pulmonary Balloon Dilatation Catheter

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

CRE PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·March 31, 2025

CRE PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·June 11, 2025

CRE PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·May 30, 2025

CRE PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·March 5, 2025

CRE PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·June 5, 2025

CRE PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·January 28, 2025

CRE PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·July 28, 2025

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 12, 2014

GENTLEPOWER LUX HANDPIECE 25LPA

FDA Adverse Event
Injury ·KAVO DENTAL GMBH·Product code EFB·October 5, 2010

TENSION FREE VAGINAL TAPE

FDA Adverse Event
Injury ·ETHICON INC·Product code FTL·December 12, 2012

CRE PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·September 30, 2025

CRE PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·May 12, 2025

CRE PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·January 10, 2025

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022

Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020