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