11 results
·
21ms
·
Sources: EU EUDAMED, US FDA
BONE NAIL W/WASHER & AN ARTHROSCOPIC INSERTION SYS
FDA 510(k)
FDA Class 2
·Orthopedic
GC Initial™
FDA UDI
Gc America Inc.·15400556708719·GC Initial™ Zr-FS Shoulder Transpa ST-30, 20g
GC Initial™
FDA UDI
Gc America Inc.·J0228751301·GC Initial™ Zr-FS Shoulder Transpa ST-30, 20g
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668109762·MCINTYRE ANTERIOR CHAMBER CAN 23GA ANG
G-Beam Fusion Beaming System
FDA UDI
ORTHOFIX SRL·18053504360629·G-BEAM STAINLESS STEEL FUSION BEAM L130MM D5.4M...
TRACHEOSTOMY CARE KIT
FDA 510(k)
FDA Class 2
·Anesthesiology
DEN-MAT SECURE ANTI-ROTATIONAL POST-CORE SYSTEM
FDA 510(k)
FDA Class 1
·Dental
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 16, 2014
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·October 19, 2010
BIOHORIZON DENTAL IMPLANT DRILL
FDA Adverse Event
Injury
·BIOHORIZONS·Product code DZE·December 12, 2012
THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105 14-451110 14-451115 14-451120 14-451125 14-451130 . The product is a metallic bone fixation system.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 4, 2020