19 results
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Sources: EU EUDAMED, US FDA
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Regulation: 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