12 results · 22ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

T2Bacteria® Panel

FDA 510(k)
FDA Class 2 ·Microbiology

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114100·SIMCOE CORTEX EXTRACTOR 21GA 0.4MM PK/10

LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400

FDA 510(k)
FDA Class 2 ·Radiology

ARDIS INTERBODY SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

NEXUS® BSA MICRO HOOK SHAVER AND TUBESET

FDA Adverse Event
Injury ·MISONIX, INC.·Product code LFL·December 13, 2023

PUMP MMT-1780KPK 670G PATHWAY BLACK MG

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·March 18, 2019

COLLEAGUE CX VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE.LTD.·Product code FRN·November 18, 2008

NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code FYD·July 22, 2011

TAPER SLEEVE ADAPTER 12/14 +8

FDA Adverse Event
Injury ·Product code KWA·July 18, 2013

OT ULTRA2 METER

FDA Adverse Event
Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 1, 2016

UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

FDA Enforcement
Class II ·Terminated·Zimmer Surgical Inc·November 12, 2014

Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

FDA Enforcement
Class II ·Terminated·Synthes, Inc.·July 22, 2015