18 results · 22ms · 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.

ARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELED

FDA 510(k)
FDA Class 2 ·Orthopedic

Chemosite

FDA UDI
Covidien LP·10884521099333·Venous Access System

OsteoMed

FDA UDI
OSTEOMED LLC·00845694002608·13mm Left L Plate

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319703243·Tissue Forceps 5-1/2" (13.8cm), 1x2 teeth

RICHARDSON ELECTRONICS

FDA registration
RICHARDSON ELECTRONICS·1 product·🇺🇸 United States

OptiMesh Multiplanar Expandable Interbody Fusion System

FDA UDI
SPINEOLOGY INC.·M7403120044·Short Portal Stem

OsteoMed

FDA UDI
OSTEOMED LLC·00845694040846·13mm Left L Plate, Sterile

OsteoMed

FDA UDI
OSTEOMED LLC·00845694063555·1.2 System 13mm Left L Plate Sterile Qty 2

FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY

FDA 510(k)
FDA Class 2 ·Orthopedic

VINYL EXAMINATION GLOVES STERILE POWEDERED

FDA 510(k)
FDA Class 1 ·General Hospital

PRECISION NOVI?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·June 27, 2025

Widex

FDA UDI
Widex A/S·05706069543247·Compass V5.7.2 CD-ROM

SOLYX SIS SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 20, 2013

NEXGEN STEMMED TIBIAL PLATE

FDA Adverse Event
Injury ·ZIMMER INC.·Product code JWH·June 7, 2011

G2 FILTER SYSTEM, FEMORAL

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·August 15, 2008

Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.

FDA Enforcement
Class II ·Ongoing·AURIS HEALTH INC·October 16, 2024

Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

FDA Enforcement
Class II ·Terminated·GA Industries·May 6, 2015

Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·April 30, 2025