12 results · 21ms · Sources: EU EUDAMED, US FDA

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TRACOE silcosoft Tracheostomy Tube

FDA 510(k)
FDA Class 2 ·Anesthesiology

Ophthalmic Ring

FDA UDI
KATENA PRODUCTS, INC.·00841668100837·FLIERINGA FIXATION RING 22MM

Omega Locking Driver

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215076566·

MCKESSON HORIZON CARDIOLOGY

FDA 510(k)
FDA Class 2 ·Radiology

ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MPACT DOUBLE MOBILITY ACETABULAR SHELL 48

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·December 21, 2020

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FKX·June 17, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 22, 2011

E-SERIES DEFIBRILLATOR

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·September 19, 2008

BINAXNOW COVID-19 AG CARD

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·April 18, 2022

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