18 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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V20 system
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Paxeon Femoral Head
FDA UDI
PAXEON RECONSTRUCTION LLC·08177570200115·Paxeon Head, Ceramic Size 28mm S
Signature Femoral Head
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215001896·
OrthoMedFlex
FDA UDI
ORTHOMEDFLEX LLC·M7161111526110·Ceramic Femoral Head, 28mm, S (-3.5 mm)
ECP HEALTH SYSTEM, MODEL 2005
FDA 510(k)
FDA Class 2
·Cardiovascular
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
SIGNATURE Head - BIOLOX Delta
FDA UDI
AMPLITUDE SAS·03701089520720·
DYNASTY® A-CLASS® STD POLY LINER 28MM GROUP B
FDA Adverse Event
Injury
·MICROPORT ORTHOPEDICS INC.·Product code JDI·April 7, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 13, 2025
I-STAT 6+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·October 9, 2017
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 7, 2013
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 27, 2011
AXSYM RUBELLA IGG ANTIBODY
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code LFX·September 10, 2008
BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code NGT·January 6, 2023
Gold-Tite Square Uniscrew Item: UNISG Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
BD POSIFLUSH¿ SP SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code NGT·February 24, 2023
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023