26 results · 24ms · 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.

NEWPORT C250 AIR COMPRESSOR MODEL C250

FDA 510(k)
FDA Class 2 ·Anesthesiology

SW

FDA UDI
SW SAFETY SOLUTIONS INC.·00616489125563·PowerChem Neoprene Exam Gloves, Extra Extra Large

LEONE SPA

FDA UDI
LEONE SPA·08033707065760·INTRAORAL ELASTICS 6,5 oz 3/8" orange

Specials

FDA UDI
Seaspine Orthopedics Corporation·10889981176990·Steep DTS Guide, 6mm

HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

SPINAL MESH SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

PYRAMESH C TITANIUM MESH

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC, INC.·Product code EZX·August 12, 2011

PYRAMESH

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code EZX·September 29, 2015

ASTERX EXPANDABLE CORPECTOMY SYSTEM

FDA Adverse Event
Injury ·MSD DEGGENDORF MFG·Product code MQP·March 4, 2019

ASTERX EXPANDABLE CORPECTOMY SYSTEM

FDA Adverse Event
Injury ·MSD DEGGENDORF MFG·Product code MQP·March 4, 2019

PYRAMESH C TITANIUM MESH

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code EZX·October 26, 2019

ULTRACISION HARMONIC ACE

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·April 8, 2013

6800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 23, 2011

VITALITY DR

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

PYRAMESH C TITANIUM MESH

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code EZX·June 27, 2020

PYRAMESH C TITANIUM MESH

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code EZX·April 22, 2019

ZEVO ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·December 19, 2018

PYRAMESH® C TITANIUM MESH

FDA Adverse Event
Malfunction ·MEDTRONIC MEDICAL COSTA RICA S.R.L.·Product code EZX·May 26, 2025

LEGION PS OXIN FEM SZ5 LT

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code JWH·February 5, 2018

6) Signa Excite (K041476 Signa Excite 1.5T and 3.0T) Signa Excite, 12x (K041476 Signa Excite 1.5T and 3.0T) The GE Signa HDe MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa HDe MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa HDe system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

FDA Recall
Terminated ·GE Healthcare, LLC·Product code LNH·November 9, 2010