14 results · 20ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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