12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Electric wheelchair
FDA 510(k)
FDA Class 2
·Physical Medicine
INSERTION TOOL
FDA 510(k)
FDA Class 2
·Cardiovascular
Sterile Silver Alginate Wound Dressing
FDA 510(k)
FDA Unclassified
·Unknown
1 ML BD INSULIN SYRINGE WITH 30 G X 8 MM BD ULTRA-FINE II¿ NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMI·April 24, 2019
BD ULTRA-FINE II SHORT NEEDLE INSULIN SYRINGE
FDA Adverse Event
Injury
·BD MEDICAL - DIABETES CARE·Product code FMF·October 8, 2019
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 27, 2023
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·November 10, 2014
COATED VICRYL (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·September 9, 2011
EZ STEER? THERMOCOOL® NAV BI-DIRECTIONAL CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code OAD·July 22, 2013
BD LUER-LOK SYRINGE 60 ML
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·March 19, 2021
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025