15 results · 21ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

RxSight Insertion Device

FDA 510(k)
FDA Class 1 ·Ophthalmic

ACDF STAND ALONE CERVICAL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·October 8, 2025

ACELL MATRISTEM WOUND SHEET

FDA 510(k)
FDA Unclassified ·Unknown

GEMORE MUSCLE CONDITIONER;

FDA 510(k)
FDA Class 2 ·Physical Medicine

ACDF STAND ALONE CERVICAL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·April 25, 2025

ANKLE ARTHRODESIS NAIL, LEFT 10X150MM

FDA Adverse Event
Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 8, 2010

ACDF STAND ALONE CERVICAL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·December 22, 2025

HUDSON CONCHATHERM NEPTUNE HEATED HUMIDIFIER

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code BTT·July 22, 2011

ANIMAS VIBE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 27, 2013

GREENLIGHT MOXY FIBER OPTIC

FDA Adverse Event
Malfunction ·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·October 22, 2014

ACDF 03.18.118 MECTA-C SA TIPEEK CAGE 18X15X6X7°

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·May 12, 2023

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

ACDF STAND ALONE CERVICAL

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code OVE·June 13, 2025

Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

FDA Enforcement
Class I ·Terminated·Boston Scientific Corporation·April 27, 2016