18 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SMITH & NEPHEW RAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16710909260·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450214817·
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587P09092670·9mm PLIF Implant 9mm Wide 26mm Length, 7 deg Lo...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450214992·
ZEUS-P
FDA UDI
SPINAL ELEMENTS·00840916153250·Zeus-P Trial, 9 x 9 x 26mm
Ardis®
FDA UDI
ZIMMER SPINE, INC.·00889024334342·
Ardis®
FDA UDI
ZIMMER SPINE, INC.·00889024333611·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1671000909260·
EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
R-SI-LINE METAL-BITE
FDA 510(k)
FDA Class 2
·Dental
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 25, 2025
AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·December 22, 2009
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 2, 2013
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG,·Product code NVZ·May 3, 2011
ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·August 1, 2008
Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·November 30, 2016
BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK6140, PAK6155, PAK6240, PAK6255, PAK6340, PAK6355, PAK6440, and PAK6455 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·January 13, 2016