27 results · 25ms · Sources: EU EUDAMED, 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