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

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0.014” Willow Guidewire

FDA 510(k)
FDA Class 2 ·Cardiovascular

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114001·CHANG HYDRO-DISSECT CANNULA 27GA

NA

FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295129363·12/14 ARTICULEZE TRIAL 48mm +1.5

BIPAP FOCUS

FDA 510(k)
FDA Class 2 ·Anesthesiology

Bi-Blade Vitrectomy Cutter

FDA 510(k)
FDA Class 2 ·Ophthalmic

RESPIRONICS

FDA Adverse Event
Malfunction ·RESPIRONICS CALIFORNIA, LLC·Product code MNS·June 8, 2021

CARETOUCH

FDA Adverse Event
Injury ·GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD·Product code DXN·July 10, 2023

Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300

FDA Enforcement
Class II ·Terminated·Anodyne Surgical·June 23, 2021

SYNCHROMED EL

FDA Adverse Event
Injury ·RICE CREEK MANUFACTURING·Product code LKK·December 5, 2008

BD VACUTAINER BLOOD COLLECTION TUBE

FDA Adverse Event
Other ·BD·Product code JKA·September 1, 2011

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 29, 2013

RESPIRONICS

FDA Adverse Event
Malfunction ·Product code MNT·May 19, 2021

Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300

FDA Recall
Terminated ·Anodyne Surgical·Product code HMX·April 21, 2021

ALINITY I RUBELLA IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFX·November 26, 2025

ALINITY I RUBELLA IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFX·November 7, 2025

ALINITY I RUBELLA IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFX·February 13, 2026

Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014