27 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee Replacement System
FDA 510(k)
FDA Class 2
·Orthopedic
Inspire™ Esthetic Provisional Composite B1
FDA UDI
DEN-MAT HOLDINGS, LLC·00359883003982·Esthetic Provisional Composite
Inspire™ Esthetic Provisional Composite B1
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172010535·Esthetic Provisional Composite
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704284676·
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690124580·Modular Offset Stem 17mm x 100mm x 4mm
ECG
FDA UDI
Zoll Medical Corporation·00847946021849·12 LEAD ECG LIMB LEAD, 7FT BLACK
EASY CUFF
FDA 510(k)
FDA Class 2
·Anesthesiology
MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE
FDA 510(k)
FDA Class 2
·Radiology
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 10, 2020
RADIFOCUS GLIDEWIRE M
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 22, 2018
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·June 7, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 24, 2011
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·September 10, 2008
CD HORIZON® FENESTRATED SCREW SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·September 3, 2024
CD HORIZON® SOLERA¿ FENESTRATED SCREW SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code NKB·July 28, 2025
CD HORIZON® SOLERA¿ FENESTRATED SCREW SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code NKB·July 28, 2025
CD HORIZON® SOLERA¿ FENESTRATED SCREW SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·April 2, 2025
CD HORIZON® SOLERA® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., HU·Product code NKB·March 20, 2026
CD HORIZON® SOLERA¿ FENESTRATED SCREW SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code MNI·December 9, 2025
CD HORIZON® SOLERA¿ FENESTRATED SCREW SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·April 16, 2024