27 results
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39ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01)
FDA 510(k)
FDA Class 2
·Cardiovascular
DELTA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613252272878·DELTA 2.2MM INSTRUMENT MODULE
Genius Total Knee System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215021597·
Crescendo Meniscal Insert CR Ultracongruent 10mm Size 2
FDA UDI
AMPLITUDE SAS·03701089524605·
NUMARIS 4VA15A
FDA 510(k)
FDA Class 2
·Radiology
KARMAN WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
EMBLEM S-ICD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LWS·January 17, 2023
FLEXTEND
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DTB·March 1, 2023
FLEXTEND
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DTB·March 2, 2023
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 23, 2013
PHYSIOMESH
FDA Adverse Event
Injury
·ETHICON·Product code FTL·April 28, 2011
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)·Product code NEW·May 12, 2009
ENDOTAK RELIANCE G
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LWS·October 5, 2023
EMBLEM S-ICD
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code LWS·May 22, 2023
ABBOTT LOW VOLTAGE LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code DTB·February 28, 2022
DREAMSTATION AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC·Product code BZD·June 14, 2022
LEAD MODEL 303
FDA Adverse Event
Malfunction
·LIVANOVA USA, INC.·Product code LYJ·August 31, 2021
LEAD MODEL 304
FDA Adverse Event
Malfunction
·LIVANOVA USA, INC.·Product code LYJ·September 25, 2020
SPRINT QUATTRO SECURE S MRI SURESCAN
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·May 7, 2024