14 results · 40ms · Sources: EU EUDAMED, US FDA

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Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source

FDA 510(k)
FDA Class 2 ·Radiology

PROVU (TM) DENTAL X-RAY SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

EZSLEEP SLEEP QUALITY RECORDER

FDA 510(k)
FDA Class 2 ·Cardiovascular

AIRVO TUBE AND CHAMBER KIT WITH NEBULIZER ADAPTER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 23, 2021

AIRVO TUBE AND CHAMBER KIT WITH NEBULIZER ADAPTER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·April 18, 2022

AIRVO2 TUBE AND CHAMBER KIT WITH NEBULIZER ADAPTER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 18, 2022

GYNECARE TVT RETROPUBIC SYSTEM

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTN·June 11, 2013

ENDOTAK RELIANCE

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVY·July 14, 2011

TANDEM T:SLIM INSULIN DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·July 16, 2014

HEATED BREATHING TUBE AND CHAMBER KIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·April 5, 2022

AIRVO TUBE AND CHAMBER KIT WITH NEBULIZER ADAPTER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 18, 2021

AIRVO TUBE AND CHAMBER KIT WITH NEBULIZER

FDA Adverse Event
Malfunction ·Product code BTT·October 7, 2021

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code CAF·November 7, 2023

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