12 results · 21ms · 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.

Tritanium PL Cage

FDA 510(k)
FDA Class 2 ·Orthopedic

EVOS Lumbar Interbody System

FDA UDI
Cutting Edge Spine, LLC·00841193110707·HA PEEK EVOS Rotate, , 14mmx11mmx 30mm , FLAT 8...

Symmetry Surgical

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482000373·Symmetry® Chisel, Puka, No 1

Metzenbaum Scissors straight 14cm

FDA UDI
CONCISE ENTERPRISES·G2021401810140·Metzenbaum Scissors are a type of surgical scis...

BOND BONE

FDA 510(k)
FDA Class 2 ·Dental

SOYALA GEL VENTED

FDA 510(k)
FDA Class 2 ·Anesthesiology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 11, 2025

6600

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 7, 2011

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·June 20, 2013

ACCU-CHEK COMPACT TEST DRUM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·September 29, 2008

SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.]

FDA Enforcement
Class II ·Terminated·SenTec AG·August 14, 2019

BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020