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

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BD Prevue™ II Peripheral Vascular Access System

FDA 510(k)
FDA Class 2 ·Radiology

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776397487·Bruns Curette, 9", angled, oval, size 4

Integra® Jarit®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780372356·Integra® Jarit® Bruns Oval Cup Curette, Angled,...

Ballard* Multi-Access Port Closed Suction System

FDA UDI
Avanos Medical, Inc.·00609038101378·BALLARD* Multi-Access Port Catheter, Double Swi...

Ballard* Multi-Access Port Closed Suction System

FDA UDI
Avanos Medical, Inc.·00609038119854·BALLARD* Multi-Access Port Catheter, Double Swi...

INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM

FDA 510(k)
FDA Class 2 ·Hematology

COMFORTSOFT SOFT DENTURE LINER SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

IMP,TSV,4.1MM,SBM,8

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·February 1, 2022

IMPLANT, ENDOSSEOUS, ROOT-FORM

FDA Adverse Event
Injury ·J DENTAL CARE SRL·Product code DZE·August 28, 2025

PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY

FDA Adverse Event
Malfunction ·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·June 2, 2025

IMP,TSV,4.1MM,SBM,8

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·October 8, 2024

IMP,TSV,4.1MM,SBM,8

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·October 8, 2024

FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 24, 2008

ACCENT DR RF

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·September 9, 2011

FLEXCATH STEERABLE SHEATH

FDA Adverse Event
Malfunction ·MEDTRONIC CRYOCATH LP·Product code DRA·July 22, 2013

Halyard Closed Suction System for Adults, Multi-Access¿Port¿Closed¿Suction¿System¿for¿Adults. Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* MULTI-PORT, DSY, ENDO 10FR; b. HALYARD* MULTI-PORT, DSY, ENDO 12FR; c. HALYARD* MULTI-PORT, DSY, ENDO, MDI 12FR; d. HALYARD* MULTI-PORT, DSY, ENDO 14FR; e. HALYARD* MULTI-PORT, DSY, TRACH 14FR; f. HALYARD* MULTI-PORT, DSY, TRACH, WP 14FR; g. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; h. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; i. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; j. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; k. HALYARD* MULTI-PORT, DSY, ENDO, MDI 16FR;

FDA Enforcement
Class II ·Terminated·Halyard Health, Inc·April 25, 2018

Model Number L111, ESSENTIO DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013