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

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CONCORDE LIFT™

FDA 510(k)
FDA Class 2 ·Orthopedic

ET III SA ULTRA WIDE SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

RHYTHMIA HDX

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·October 16, 2025

LEONARD 10 FR DL CVC, PEEL-APART INTRODUCER KIT

FDA Adverse Event
Malfunction ·BARD ACCESS SYSTEMS INC.·Product code LJS·October 10, 2014

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

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

HOT BIOPSY FORCEPS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - COSTA RICA·Product code KGE·July 23, 2011

Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]

FDA Enforcement
Class II ·Terminated·Ecolab Inc·October 31, 2018