168 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Integral Titanium Cervical Interbody
FDA 510(k)
FDA Class 2
·Orthopedic
HEALIX ADVANCE BR ANCHOR w/DYNACORD
FDA UDI
Medos International Sàrl·10886705029532·HEALIX ADVANCE BR ANCHOR w/DYNACORD AND NEEDLES...
Altus Spine Interbody Fusion System
FDA UDI
Altus Spine, LLC·00843210131641·Broach Trial
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193100159·EVOS Straight HA PEEK 15mm x 9mm x 22mm Biconve...
18M - Class A 21 - Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588620152·18M - Class A 21 - Metal
Sapphire NC ULTRA Coronary Dilatation Catheter
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955982149·
Meridian
FDA UDI
Seaspine Orthopedics Corporation·10889981247270·No-Profile Interbody, 39mm x 27mm x 20mm, 15 Deg
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE
FDA 510(k)
FDA Class 2
·Orthopedic
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 9, 2015
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 6, 2008
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORP·Product code MKJ·August 17, 2011
ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·July 5, 2013
GUARDWIRE TEMPORARY OCCLUSION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC, INC·Product code DXE·September 21, 2016
BD NANO¿ 2ND GEN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·November 22, 2022
BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·October 25, 2023
BD NANO¿ 2ND GEN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·February 14, 2022
KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KWIK-STIK 6-pack Enterococcus faecalis derived from ATCC 51299
FDA Enforcement
Class II
·Terminated·Microbiologics Inc·March 9, 2022
KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299
FDA Enforcement
Class II
·Terminated·Microbiologics Inc·March 9, 2022
ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests Product Usage: For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT/ADVIA Centaur CP systems. Cardiac troponin I determinations aid in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction (MI) or increased probability of ischemic events requiring urgent revascularization procedures.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·July 29, 2015