27 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Tritanium PL Cage
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699564·GENUMEDI PSS BLUE, SIZE IV
CoRoent
FDA UDI
Nuvasive, Inc.·00887517566430·CoRoent Ant TLIF PEEK, 15x12x30mm 4°
2.0 LACTOSORB SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036055066·
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690124252·Modular Offset Stem 13mm x 100mm x 4mm
SUPER PORCELAIN EX-3 PRESS
FDA 510(k)
FDA Class 2
·Dental
BREEZE C MODEL C (3W), BREEZE C (4W)
FDA 510(k)
FDA Class 2
·Physical Medicine
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 10, 2020
TRANSVENE
FDA Adverse Event
Injury
·MEDTRONIC, B.V.·Product code NVY·June 7, 2013
CONFIDENCE INTRODUCER NEEDLE, SIDE HOLE, 13G 4"
FDA Adverse Event
Malfunction
·DEPUY SPINE, INC.·Product code DYB·June 23, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·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
Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile EO. Microtek Medical, Inc., Columbus, MS 39702.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 14, 2016
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
CD HORIZON® SOLERA FENESTRATED SCREW SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·November 4, 2022