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

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ENT Nasopharyngoscope and Accessories

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

CoRoent

FDA UDI
Nuvasive, Inc.·00887517298935·CoRoent® XL-XW, 14x26x50mm

Dornier MedTech

FDA UDI
Dornier MedTech GmbH·04049958003707·Medilas H30 Solvo Holmium Laser with wireless f...

HAWKEYE™ Vertebral Body Replacement (VBR)

FDA UDI
Choice Spine, LP·00840996101097·VBR,SPACER,12X14X50,0 DEG

OsteoMed

FDA UDI
OSTEOMED LLC·00845694020688·FPS 4.0mm x 50mm Standard Screw

PMT® Halo Systems

FDA UDI
PMT CORPORATION·00650551113942·HALO, CTLSO VEST SMALL, COOLMAX LINER, 1211-1 X...

HONOUR™ Spacer System

FDA UDI
NEXXT SPINE, LLC·00889929002933·Cervical PEEK, 6°, 14mm W x 12mm D x 5mm H

Augmented VaultLock Glenoid

FDA 510(k)
FDA Class 2 ·Orthopedic

HEX-LOCK TEMPORARY ABUTMENT

FDA 510(k)
FDA Class 2 ·Dental

HONOUR™ Spacer System

FDA UDI
NEXXT SPINE, LLC·00889929002940·Cervical PEEK, 0°, 12x14x5

HONOUR™ Spacer System

FDA UDI
NEXXT SPINE, LLC·00889929002957·Cervical PEEK, 10°, 14mm W x 12mm D x 5mm H

OsteoMed

FDA UDI
OSTEOMED LLC·00845694075022·FPS 4.0 x 50mm Screw Sterile Qty 2

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 7, 2025

HEARTSTART MRX-EMS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code LDD·October 23, 2008

RSP SHOULDER

FDA Adverse Event
Other ·ENCORE MEDICAL, L.P.·Product code KWS·August 2, 2011

TALENT TAA

FDA Adverse Event
Death ·MEDTRONIC CARDIOVASCULAR·Product code MIH·July 9, 2013

Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019