13 results
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18ms
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Sources: EU EUDAMED, US FDA
HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Acumed
FDA UDI
Provision·B504OM8023790·
ACUMED
FDA UDI
Acumed LLC·10806378095559·2.8mm QR Drill, w/ depth marks
Reprocessed 2.8mm Surgibit Drill, Depth Markings
FDA UDI
SURETEK MEDICAL·B3908023791·
LTF-Y0009; MAJ-YOO41; XOEV-3D1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
M2A 28MM RINGLOC LINER
FDA 510(k)
FDA Class 3
·Orthopedic
NA
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.·Product code JAK·February 21, 2014
AMPLATZER
FDA Adverse Event
Injury
·AGA MEDICAL CORP·Product code MLV·October 15, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 5, 2007
BD EMERALD¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·October 11, 2018
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017