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