7,620 results
·
10ms
·
Sources: EU EUDAMED, US FDA
ORAcollect RNA: ORE-100
FDA Enforcement
Class II
·Ongoing·DNA Genotek Inc.·April 27, 2022
O-Ring Abutment 4.1mm(D) x 2mm(H) Item: OSO20 Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
O-Ring Abutment 4.1mm(D) x 4mm(H) Item: OSO40 Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
O-Ring Abutment 4.1mm(D) x 6mm(H) Item: OSO60 Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The Gomco clamp is intended to be used for circumcision surgeries
FDA Enforcement
Class II
·Terminated·Aesculap Implant Systems LLC·January 11, 2017
EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·July 8, 2015
Ocean Water Seal Chest Drain, SINGLE W/AC P/N: 2002-100
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·July 8, 2015
Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·July 8, 2015
Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·July 8, 2015
Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines, models 2008K, 2008K2, 2008K@Home and 2008T
FDA Enforcement
Class II
·Terminated·Fresenius Medical Care Holdings, Inc.·July 17, 2013
Cardiosave Rescue. Model Number: 0998-00-0800-83.
FDA Enforcement
Class II
·Ongoing·Datascope Corp.·March 15, 2023
6IN PRESSURE TUBING, List Number MX20617
FDA Enforcement
Class II
·Ongoing·Smiths Medical Asd Inc·January 24, 2024
HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP
FDA Enforcement
Class II
·Ongoing·Smiths Medical Asd Inc·January 24, 2024
Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R
FDA Enforcement
Class II
·Ongoing·Smiths Medical Asd Inc·January 24, 2024
HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP
FDA Enforcement
Class II
·Ongoing·Smiths Medical Asd Inc·January 24, 2024
Medex LOGICAL CATH LAB KIT, List Number M20754
FDA Enforcement
Class II
·Ongoing·Smiths Medical Asd Inc·January 24, 2024
20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR
FDA Enforcement
Class II
·Ongoing·Smiths Medical Asd Inc·January 24, 2024
1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL
FDA Enforcement
Class II
·Ongoing·Smiths Medical Asd Inc·January 24, 2024
48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R
FDA Enforcement
Class II
·Ongoing·Smiths Medical Asd Inc·January 24, 2024
Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R
FDA Enforcement
Class II
·Ongoing·Smiths Medical Asd Inc·January 24, 2024