19 results · 30ms · Sources: EU EUDAMED, US FDA

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FACTOR VIII ANTIBODY SCREEN

FDA 510(k)
FDA Class 2 ·Hematology

XLIF

FDA UDI
Nuvasive, Inc.·00195377026385·XLIF AMS Trial, 8x22mm 5° Lollipop

XLIF

FDA UDI
Nuvasive, Inc.·00887517053770·XLIF AMS Trial, 8x22mm 5° Modular

N.A.

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR30822051·Sheet springs 0,15 x 23 x 5

NOBELACTIVE INTERNAL RP 4.3X8.5MM

FDA Adverse Event
Injury ·NOBEL BIOCARE AB·Product code DZE·August 17, 2020

NOBELACTIVE INTERNAL NP 3.5X8.5MM

FDA Adverse Event
Injury ·NOBEL BIOCARE AB·Product code DZE·September 9, 2020

NOBELACTIVE INTERNAL NP 3.5X8.5MM

FDA Adverse Event
Injury ·NOBEL BIOCARE AB·Product code DZE·September 9, 2020

NOBELACTIVE INTERNAL RP 4.3X8.5MM

FDA Adverse Event
Injury ·NOBEL BIOCARE AB·Product code DZE·August 17, 2020

GLUCOMETER DEX TEST SENSOR

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CARONY

FDA 510(k)
FDA Class 1 ·Physical Medicine

WAVEWRITER ALPHA?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 15, 2025

NUMERIS TETHERED COAGULATION SYSTEM WITH VISITRAX

FDA Adverse Event
Death ·ATRICURE, INC.·Product code OCL·November 13, 2018

ANIMAS VIBE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 29, 2013

ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

FDA Adverse Event
Death ·CORDIS NEUROVASCULAR, INC.·Product code NJE·May 9, 2011

ENDO GIA ROTICULATOR 45-4.8 SULU

FDA Adverse Event
Injury ·NORTH HAVEN - USS·Product code GDW·July 25, 2008

LifeScan brand OneTouch FastTake Blood Glucose Meter

FDA Recall
Terminated ·Lifescan Inc·Product code NBW·April 11, 2005

CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015