14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Elite HV Radial
FDA 510(k)
FDA Class 2
·Cardiovascular
Centronail Titanium Universal Femoral Nailing System
FDA UDI
ORTHOFIX SRL·18032937160983·K-WIRE 2 MM
PREVADH MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYNTHES 6.0 COCR AND CPT TI-3 RODS
FDA 510(k)
FDA Class 2
·Orthopedic
BALL HEADS: COCR BALL HEAD 12/14 Ø 28 SIZE M 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·September 6, 2024
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
FDA Adverse Event
Injury
·SYNTHES USA·Product code NKB·September 16, 2016
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 23, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 17, 2013
GRIPPER MICRO BLUNT CANNULA, NON0CORING SAFETY NEEDLE
FDA Adverse Event
Injury
·SMITHS MEDICAL, INC.·Product code FPA·September 25, 2014
MPACT DOUBLE MOBILITY ACETABULAR SHELL 52
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·August 25, 2021
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
FDA Adverse Event
Injury
·SYNTHES USA·Product code NKB·December 29, 2015
IPSOGEN JAK2 PCR KIT IVD
FDA Adverse Event
QIAGEN GMBH·Product code PSU·September 4, 2018
LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMG
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·September 19, 2019
Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]
FDA Enforcement
Class II
·Terminated·Ecolab Inc·October 31, 2018