12 results · 20ms · Sources: EU EUDAMED, 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