14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System
FDA 510(k)
FDA Class 2
·Orthopedic
ELMED
FDA UDI
ELMED INCORPORATED·00842180166721·Yasargil Standard Reusable Occlusion Clip, Stra...
BLUE COLOUR POWDER FREE BARRIERPRO POLYMER BP2000 POLYBUTADIENE COPOLYMER EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK)
FDA 510(k)
FDA Class 1
·General Hospital
PARTIAL ARTICULAR SURFACE
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code HSX·April 20, 2023
PARTIAL ARTICULAR SURFACE
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code HSX·July 25, 2022
HAMILTON MEDICAL AG
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·January 26, 2024
HAMILTON MEDICAL AG
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·March 6, 2024
HAMILTON MEDICAL AG
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·February 13, 2024
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
GIA UNIVERSAL
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code GDW·July 1, 2011
8MM MCS TIP COVER ACCESSORY
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC.·Product code GEI·September 12, 2008
MEDISLIM
FDA Adverse Event
Injury
·MEDICREATIONS, LLC·Product code GEX·April 27, 2020
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