28 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CATSmart
FDA 510(k)
FDA Class 2
·Anesthesiology
ELMED
FDA UDI
ELMED INCORPORATED·00842180167766·DUNN-DAUTREY TYPE POSTERIOR RETR 65X50MM
N/A
FDA UDI
Ortho Development Corporation·00822409129645·Uni Knee Keeled Tibial Tray Trial Size 3 Left
CYFRA 21-1 EIA MODEL 211-10
FDA 510(k)
FDA Class 2
·Immunology
SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
MAXZERO
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·March 17, 2026
UNIVERSAL STRAIGHT SET 2Y MLL
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FPA·November 21, 2007
NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184 (01)06438147295708(17)180531(10)653414 (01)06438147295708(17)180531(10)653657 (01)06438147295708(17)180630(10)654923 (01)06438147295708(17)180630(10)655680 (01)06438147295708(17)180630(10)655300 (01)06438147295708(17)180630(10)654924 (01)06438147295708(17)180831(10)656025 (01)06438147295708(17)180831(10)657055 (01)06438147295708(17)180831(10)656170 (01)06438147295708(17)180831(10)656320 (01)06438147295708(17)181031(10)657768 (01)06438147295708(17)181031(10)657513 (01)06438147295708(17)181031(10)658006
FDA Recall
Terminated
·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code NQL·November 2, 2017
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Death
·MEDTRONIC CARDIOVASCULAR IRELAND·Product code MIH·July 22, 2011
TALENT
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·June 20, 2013
ENDOSTAT II ELECTROSURGICAL UNIT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·September 23, 2008
NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184 (01)06438147295708(17)180531(10)653414 (01)06438147295708(17)180531(10)653657 (01)06438147295708(17)180630(10)654923 (01)06438147295708(17)180630(10)655680 (01)06438147295708(17)180630(10)655300 (01)06438147295708(17)180630(10)654924 (01)06438147295708(17)180831(10)656025 (01)06438147295708(17)180831(10)657055 (01)06438147295708(17)180831(10)656170 (01)06438147295708(17)180831(10)656320 (01)06438147295708(17)181031(10)657768 (01)06438147295708(17)181031(10)657513 (01)06438147295708(17)181031(10)658006
FDA Enforcement
Class II
·Terminated·PerkinElmer Life and Analytical Sciences, Wallac, OY·May 16, 2018
BD MAXZERO¿ MULTI-FUSE PRESSURE RATED EXTENSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·March 21, 2023
BD MAXZERO¿ EXTENSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·June 10, 2022
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CFN MEXICO 215 SA DE CV·Product code FPA·May 12, 2020
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019
BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 19, 2023
BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 18, 2023
SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.]
FDA Enforcement
Class II
·Terminated·SenTec AG·August 14, 2019
Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. (REF 00667) The STA¿ - N¿oplastine¿ CI Plus kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R¿, STA Compact¿ and STA Satellite¿. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875).
FDA Enforcement
Class II
·Terminated·Diagnostica Stago, Inc.·September 19, 2018