10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses
FDA 510(k)
FDA Class 2
·Ophthalmic
NA
FDA UDI
DEPUY MITEK, LLC·10886705025534·SMALL SOFT TISSUE DILATOR
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383514743·"An absorbent paper points is an endodontic pap...
LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM
FDA 510(k)
FDA Class 2
·Cardiovascular
VHS PEDIATRIC HIP SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCICENCS IMPLANTS SA·Product code GWM·August 19, 2019
RADIESSE DERMAL FILLER
FDA Adverse Event
Injury
·BIOFORM MEDICAL·Product code LMH·October 23, 2008
UNICEL DXC 800 SYNCHRON SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·August 5, 2011
INCEPTA
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021