95 results · 25ms · Sources: EU EUDAMED, US FDA

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HEMASORB APPLY

FDA 510(k)
FDA Unclassified ·Unknown

ArgenZ HT+ 98x16 B2

FDA UDI
ARGEN CORPORATION, THE·D818121953·Dental porcelain/ceramic restoration kit

MITEK PDS/PGA STAPLE

FDA 510(k)
FDA Class 2 ·Orthopedic

SMDIA-1000

FDA 510(k)
FDA Class 2 ·Anesthesiology

CELLEX PHOTOPHERESIS MACHINE AND DISPOSABLE SET

FDA Adverse Event
Malfunction ·THERAKOS·Product code LNR·May 15, 2013

TRIMA ACCEL PLT, PLS, RBC SET

FDA Adverse Event
Other ·CARIDIANBCT·Product code LKN·June 1, 2011

LIFEPAK 20 DEFIBRILLATOR/MONITOR

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

OMNIPOD INSULIN PUMP

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code LZG·October 11, 2019

OMNIPOD INSULIN PUMP

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code LZG·October 11, 2019

PEN NDL 31GA 8MM 100 BX 1200 USA

FDA Adverse Event
Injury ·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·December 12, 2024

OMNIPOD INSULIN PUMP

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code LZG·April 29, 2019

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

OMNIPOD INSULIN PUMP

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code LZG·January 31, 2020

OMNIPOD INSULIN PUMP

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code LZG·January 17, 2020

OMNIPOD INSULIN PUMP

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code LZG·January 3, 2020

OMNIPOD INSULIN PUMP

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code LZG·February 4, 2020

OMNIPOD INSULIN PUMP

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code LZG·January 13, 2020

OMNIPOD INSULIN PUMP

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code LZG·February 4, 2020

OMNIPOD INSULIN PUMP

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code LZG·November 6, 2019

OMNIPOD INSULIN PUMP

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code LZG·November 11, 2019