13 results · 19ms · Sources: EU EUDAMED, US FDA

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NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)

FDA 510(k)
FDA Class 2 ·Microbiology

BD BBL™ Sensi-Disc™ Moxifloxacin 5 µg

FDA UDI
BECTON, DICKINSON AND COMPANY·30382902317587·BD BBL™ Sensi-Disc™ Moxifloxacin 5 µg

LOCKING SCREW, FULLY THREADED 5X45 MM

FDA Adverse Event
Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 30, 2009

ACMI M4 TELESCOPES

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

SURGEN U

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231758¿

FDA Enforcement
Class II ·Ongoing·Becton Dickinson & Co.·February 14, 2024

NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

FDA Adverse Event
Injury ·COCHLEAR LTD .·Product code MCM·November 6, 2014

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 1, 2011

VASO VIEW HEMOPRO

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·July 15, 2013

BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231758

FDA Recall
Open, Classified ·Becton Dickinson & Co.·Product code JTN·January 8, 2024

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

Revogene, Catalog no. 610210. IVD test instrument

FDA Enforcement
Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022