16 results · 20ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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