17 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Single Use Injector
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LAGLOVE BRAND NITRILE EXAMINATION GLOVES POWDERED, NON STERILE (PINK COLOR)
FDA 510(k)
FDA Class 1
·General Hospital
MYNX ACE 6F/7F VASCULAR CLOSURE DEVICE
FDA Adverse Event
Injury
·ACCESSCLOSURE, INC.·Product code MGB·October 22, 2014
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·August 5, 2011
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 19, 2013
RHYTHMIA HDX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·October 16, 2025
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·August 23, 2021
ULTRATHANE SUPRAPUBIC CATHETER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code KOB·August 23, 2022
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·March 17, 2022
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·March 17, 2022
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·March 17, 2022
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·March 17, 2022
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·August 23, 2021
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·July 21, 2021
Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001
FDA Enforcement
Class II
·Ongoing·Cook Vandergrift, Inc.·September 13, 2023
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018