15 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Motor and Apex Module (MaAM)
FDA 510(k)
FDA Class 1
·Dental
Q-FIX
FDA UDI
Smith & Nephew, Inc.·00885556724620·DISPOSABLE KIT, HIP FOR 1.8MM
...
Smith and Nephew
FDA UDI
Provision·00810041639790·
Smith and Nephew
FDA UDI
Provision·B504OM2518110·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167312518110·
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167322518110·
Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
coraForce and coraFlex Support Catheters
FDA 510(k)
FDA Class 2
·Cardiovascular
DISPOSABLE KIT HIP FOR 1.8MM Q-FIX IMP
FDA Adverse Event
Malfunction
·ARTHROCARE CORPORATION·Product code MBI·March 26, 2026
LOGIC TIBIA PS MOD INSRT SZ 3.5 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 5, 2024
FUSION NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·November 14, 2014
EXTENSION SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·September 16, 2011
NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
FDA Adverse Event
Injury
·HOLOGIC·Product code MNB·July 18, 2013
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
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023