11 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.

P200DTx

FDA 510(k)
FDA Class 2 ·Ophthalmic

Equator

FDA UDI
Preat Corporation·00842092180006·Equator Abutment for Astra EV 3.0 x 7mm

AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS

FDA 510(k)
FDA Class 2 ·Orthopedic

ORTHOSIS,PEDICLE SPINAL FIXATION

FDA Adverse Event
Injury ·SYNTHES USA·Product code MNI·December 8, 2015

FLAT SILICONE DRAIN

FDA Adverse Event
Injury ·MEDLINE INDUSTRIES, INC.·Product code GBX·May 22, 2013

CHARGING SYSTEM

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 23, 2014

TRIDENT 0 DEG CONSTRAINED INSERT 22D

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code KWZ·June 22, 2011

ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

FDA Adverse Event
Injury ·SYNTHES USA·Product code NKB·March 25, 2015

PKG, METZENBAUM SCISSORS, CURVED LONG, P/N 0250080265. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

FDA Enforcement
Class II ·Terminated·Stryker Endoscopy·December 24, 2014

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022