11 results
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18ms
·
Sources: EU EUDAMED, US FDA
BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
GYNECARE X-TRACT MORCELLATOR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code HET·June 8, 2006
PROBEAT-CR
FDA 510(k)
FDA Class 2
·Radiology
CONPHAR FINGERTIP SUCTION CONTROL
FDA 510(k)
FDA Class 2
·General Hospital
TITANIUM SCREW LOW PROFILE 5X40MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWT·November 18, 2016
TITANIUM SCREW LOW PROFILE 5X40MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWT·November 18, 2016
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
MEDEL S.P.A.·Product code BTI·March 6, 2013
ATTAIN ABILITY
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·February 15, 2011
CAPSURE SP NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 8, 2014
Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·July 1, 2015
Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024