28 results · 27ms · Sources: EU EUDAMED, US FDA

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Diamondback 360 Peripheral Orbital Atherectomy System

FDA 510(k)
FDA Class 2 ·Cardiovascular

2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES

FDA 510(k)
FDA Class 2 ·Orthopedic

ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·June 10, 2020

2.4MM VA LOCKING SCREW STARDRIVE 22MM

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·June 25, 2013

APOLLO GENERATOR

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code GWG·June 11, 2015

VA LOCKSCR Ø2.4 SELF-TAP L18 TAN

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code HRS·July 15, 2013

CAPSUREFIX MRI

FDA Adverse Event
Injury ·MPRI·Product code NVN·June 7, 2013

7900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·June 24, 2011

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
Malfunction ·INVAMEX·Product code IOR·October 8, 2014

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

2.4MM TI LOCKING SCR SLF-TPN WITH STARDRIVE RECESS 18MM

FDA Adverse Event
Malfunction ·SYNTHES BETTLACH·Product code HWC·June 21, 2017

CD HORIZON® SOLERA® SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., HU·Product code NKB·March 20, 2026

SCREW, FIXATION, BONE

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code HWC·December 24, 2015

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code HWC·July 30, 2015

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