16 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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ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·H65820200961·Channels K-Files 25mm
Channels
FDA UDI
HENRY SCHEIN, INC.·10304040039080·Channels K-Files 25mm, #30
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·10843717100987·Burs Finishing FG 7404, Pkg/5
Megadyne
FDA UDI
MEGADYNE MEDICAL PRODUCTS, INC.·10614559104309·PCB, Power Conversion Assembly, For Mega Power ...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450156285·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450156360·
TAMPAX SATIN TAMPONS, CLOSED END FLUSHABLE APPLICATOR; TAMPAX TAMPONS, OPEN END FLUSHABLE APPLICATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686
FDA 510(k)
FDA Class 2
·Clinical Toxicology
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code LFR·May 25, 2007
ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIO·March 25, 2013
UNKNOWN DEPUY AMK TIBIAL INSERT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·March 11, 2011
Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
UNKNOWN
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code GCJ·June 8, 2018
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024