9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
REMEL
FDA UDI
REMEL, INC.·00848838005749·Andrades Broth w/1% Lactose 20/PK
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306801471·Adson Tissue Forceps - Platform 1x2 Teeth, Serr...
PROFILE II ER
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERFREE
FDA 510(k)
FDA Class 1
·General Hospital
PROCEED* MULTI-LAYER LAMINATE MESH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·April 16, 2013
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 17, 2008
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 15, 2011
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024