18 results · 20ms · Sources: EU EUDAMED, US FDA

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restor3d TiDAL Lumbar Interbody Fusion Device

FDA 510(k)
FDA Class 2 ·Orthopedic

ambIT

FDA UDI
SUMMIT MEDICAL PRODUCTS, INC.·00857595005725·Cassette - Filter, Male Neuraxial Connector

ambIT* Cassette - Filter, Male Neuraxial Connector

FDA UDI
Avanos Medical, Inc.·00193494000387·ambIT* Cassette - Filter, Male Neuraxial Connector

NA

FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540366795·Drill Guide, Eccentric, For 2.3mm Screws

LEONE SPA

FDA UDI
LEONE SPA·08033707022503·CALIBRA BANDS 2ND MOLAR n.SUR 23

VEO® Lateral Interbody Fusion System

FDA UDI
Choice Spine, LP·00840996134408·LATERAL,RONGEUR,PITUITARY,6

BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757

FDA 510(k)
FDA Class 2 ·General Hospital

Biolign® Roto-Loc Cervical Plate System

FDA 510(k)
FDA Class 2 ·Orthopedic

UNKNOWN BD NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMI·March 18, 2024

NONE

FDA Adverse Event
Other ·ENCORE MEDICAL, L.P.·Product code HSH·October 29, 2008

INFUSOR

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·August 23, 2011

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013

AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·February 21, 2018

BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue.

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·March 7, 2018

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

FDA Enforcement
Class II ·Terminated·Cook Inc.·November 27, 2019

BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021