16 results
·
21ms
·
Sources: EU EUDAMED, US FDA
True Flow Valvuloplasty Perfusion Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Signature Femoral Head
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215001919·
Lightweight Drill Guide
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215114251·
Paxeon Femoral Head
FDA UDI
PAXEON RECONSTRUCTION LLC·08177570200139·Paxeon Head, Ceramic Size 28mm L
OrthoMedFlex
FDA UDI
ORTHOMEDFLEX LLC·M7161111526130·Ceramic Femoral Head, 28mm, L (+3.5 mm)
LINEAR? ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·June 16, 2025
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
INTEGRITY(TM)
FDA 510(k)
FDA Class 2
·Radiology
SIGNATURE Head - BIOLOX Delta
FDA UDI
AMPLITUDE SAS·03701089520744·
BD VACUTAINER® SST¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·October 4, 2024
ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 7, 2013
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·July 7, 2011
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 8, 2014
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