14 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HATRIC, 6&7MM, 9&10MM, 11&12MM, 14&15MM, MODELS AR-13000B-07, -10, -12, -15
FDA 510(k)
FDA Class 2
·Orthopedic
Leksell Stereotactic System
FDA UDI
Elekta Solutions AB·07340201503171·Leksell MPS Arc w Counter Scale - ARC STOP SLIDE
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120403811·Abrasive, green, medium grit
Myo/Wire II
FDA UDI
A & E MEDICAL CORPORATION·10841291101895·SS Suture, 7 per sleeve
INDO-GERMAN SURGICAL CORPORATION
FDA registration
INDO-GERMAN SURGICAL CORPORATION·49 products·🇮🇳 India
D.SIGN 30
FDA 510(k)
FDA Class 2
·Dental
EXPANDABLE KNEE
FDA 510(k)
FDA Class 2
·Orthopedic
ACL ADVANCE
FDA Adverse Event
INSTRUMENTATION LABORATORY CO.·Product code JPA·July 13, 2005
PELVICOL ACELLULAR COLLIGEN MATRIX
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE·Product code FTL·March 25, 2013
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 15, 2011
CYPHER SIROLIMUS-ELUTING CORONARY SYSTEM
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code NIQ·May 6, 2008
HUIBREGTSE NEEDLE KNIFE PAPILLOTOME
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNS·July 19, 2022
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 2038437-015 ; 6) 2038437-0XX; 7) 2109571-007; 8) 2109571-010; 9) 2109571-011; 10) 2109571-012; 11) MANLEGACY111; 12) MANLEGACY112; 13) MANLEGACY47; 14) P00011TS.
FDA Enforcement
Class II
·Ongoing·GE Healthcare·April 9, 2025