14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Comprehensive® Shoulder System
FDA UDI
Biomet Orthopedics, LLC·00887868267635·
COMPREHENSIVE SHOULDER SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304554146·
5570 3L SYRINGE
FDA UDI
HANS RUDOLPH, INC.·00817136025568·5570 3L SYR HRI TOURQ SDI-MIR
INPECTRA STO2 SPOT CHECK
FDA 510(k)
FDA Class 2
·Cardiovascular
SOFT PLUG ABSORBABLE PLUG-SA
FDA 510(k)
FDA Unclassified
·Unknown
VERCISE GENUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·June 30, 2023
EXTENSION SET WITH T-CONN. SL
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code FPA·October 3, 2013
IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·February 28, 2014
PELORIS RAPID TISSUE PROCESSOR
FDA Adverse Event
Injury
·LEICA BIOSYSTEMS MELBOURNE·Product code IEO·May 8, 2013
ALARIS SE PUMP ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FPA·May 24, 2011
BD SYRINGE 0.5ML 30GA 8MM 10BAG 500 CA
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·April 22, 2019
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025