13 results
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19ms
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Sources: EU EUDAMED, US FDA
CKG 8000
FDA 510(k)
FDA Class 2
·Cardiovascular
Total Foot System 2
FDA UDI
Smith & Nephew, Inc.·00885556838693·2.2MM PLATE LOCKING SCREW 20MM
Integra® Total Foot System
FDA UDI
Ascension Orthopedics, Inc.·10381780119081·The locking forefoot screw is used in the Integ...
24M - Class A & BBP 21 - Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588620206·24M - Class A & BBP 21 - Metal
ZAVATION MODULAR MIS HEAD ASSEMBLY
FDA UDI
Zavation LLC·00197157069629·MODULAR MIS HEAD ASSEMBLY - 20MM REDUCTION
PHOTON PHOTON PLUS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
JUSTWO MODEL TME-601 ROOT APEX LOCATOR
FDA 510(k)
FDA Unclassified
·Unknown
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 20, 2014
DEROYAL
FDA Adverse Event
Malfunction
·DEROYAL INTERCONTINENTAL, S.L.R.·Product code HIF·October 3, 2012
ECHELON*FLEX60
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·September 1, 2010
COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·May 5, 2025
IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·August 20, 2014
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020