13 results · 24ms · Sources: EU EUDAMED, US FDA

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COUGHASSIST T70 DEVICE

FDA 510(k)
FDA Class 2 ·Anesthesiology

ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058

FDA 510(k)
FDA Class 2 ·Cardiovascular

TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES

FDA 510(k)
FDA Class 2 ·Cardiovascular

ENDURO MENISCAL COMPONENT F2 22MM

FDA Adverse Event
Malfunction ·AESCULAP AG & CO. KG·Product code KRO·December 9, 2014

ENDURO MENISCAL COMPONENT F2 10MM

FDA Adverse Event
Malfunction ·AESCULAP AG AND CO. KG·Product code KRO·January 14, 2015

EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM

FDA Adverse Event
Malfunction ·EXACTECH, INC.·Product code KWT·October 6, 2022

SYNCRA CRT-P

FDA Adverse Event
Death ·IPG MFG SWITZERLAND·Product code NVZ·May 21, 2013

QUIKDRIVE BATTERY POWERED SCREWDRIVER MINI

FDA Adverse Event
Malfunction ·STRYKER OSTEOSYNTHESIS FREIBURG·Product code LXH·May 23, 2011

LIFEPAK 20 DEFIBRILLATOR/MONITOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·August 13, 2008

BD ULTRA-FINE MINI PEN NEEDLES 5MM (3/16) 31G

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·July 1, 2020

ENDURO MENISCAL COMPONENT F1 10MM

FDA Adverse Event
Injury ·AESCULAP IMPLANT SYSTEMS·Product code KRO·October 11, 2016

Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

FDA Enforcement
Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

FDA Recall
Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code EOQ·September 25, 2023