12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MetaSystems Probes
FDA UDI
MetaSystems Probes GmbH·04251315809857·XL t(8;14) MYC/IGH DF, 10x 100µl, Translocation...
KAIYANG STEEL WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01
FDA 510(k)
FDA Class 2
·Immunology
VUE PACS
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD.·Product code LLZ·November 21, 2025
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·May 14, 2013
LIGACLIP** CLIP APPLIER - SMALL
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDO·September 23, 2014
MK1 POOL LIFT
FDA Adverse Event
Malfunction
·MEDIBO MEDICAL PRODUCTS NV·Product code FSA·April 7, 2011
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025