10 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TOKUSO REBASE MR. BOND
FDA 510(k)
FDA Class 2
·Dental
PRESTIGE LP™
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994490452·TRIAL 6973245 IMPLANT
Edge™ Carbides FG 245 Amalgam Operative Carbide Bur Sample Pack
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172010429·Dental surgical bur
AR DIACOAT SINGLE VISION LENSES
FDA 510(k)
FDA Class 1
·Ophthalmic
EXTENDED VERTIFLEX SPINAL SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code ITI·February 21, 2013
IMMERSION HYDROBATH
FDA Adverse Event
Malfunction
·INVACARE CLEVELAND STREET·Product code ILJ·August 1, 2014
CE INFUSOR, LV 5 ML/H,12 PACK
FDA Adverse Event
Malfunction
·Product code MEB·January 28, 2011
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·July 11, 2017
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024