15 results · 26ms · Sources: EU EUDAMED, US FDA

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Medline ReNewal Reprocessed Endopath Endoscopic Instruments

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

2.0 LACTOSORB SYSTEM

FDA UDI
BIOMET MICROFIXATION, INC·00841036055165·

PATRIOT TRANSCONTINENTAL M SPACERS

FDA 510(k)
FDA Class 2 ·Orthopedic

STIMUPLEX HNS-12, MODEL 4892098

FDA 510(k)
FDA Class 2 ·Anesthesiology

UNKNOWN GAMMA3 LONG NAIL

FDA Adverse Event
Injury ·STRYKER TRAUMA KIEL·Product code HSB·March 9, 2021

PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

FDA Adverse Event
Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·June 7, 2013

ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)

FDA Adverse Event
Malfunction ·ANGIOSCORE, INC.·Product code LIT·October 3, 2014

INTERSTIM

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code EZW·June 23, 2011

UNKNOWN GAMMA3 SHORT NAIL

FDA Adverse Event
Injury ·STRYKER TRAUMA KIEL·Product code HSB·March 9, 2021

UNKNOWN GAMMA3 LONG NAIL CASE 3

FDA Adverse Event
Injury ·STRYKER TRAUMA KIEL·Product code HSB·March 9, 2021

UNKNOWN GAMMA3 LONG NAIL CASE 2

FDA Adverse Event
Injury ·STRYKER TRAUMA KIEL·Product code HSB·March 9, 2021

UNKNOWN GAMMA3 LONG NAIL CASE 1

FDA Adverse Event
Injury ·STRYKER TRAUMA KIEL·Product code HSB·March 9, 2021

TRUE METRIX AIR

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·June 23, 2025

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

CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024