17 results
·
32ms
·
Sources: EU EUDAMED, US FDA
BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·August 13, 2019
RESUSCI INFLATE-A-SHIELD CPR BARRIER
FDA 510(k)
FDA Class 2
·Anesthesiology
GALEMED NEB-EASY NEBULIZER
FDA 510(k)
FDA Class 2
·Anesthesiology
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·July 31, 2019
UNICEL® DXC 800 SYNCHRON® SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·April 29, 2013
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·April 11, 2011
ACUITY
FDA Adverse Event
Injury
·VARIAN MEDICAL SYSTEMS·Product code KPQ·July 25, 2008
Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code NIQ·June 9, 2023
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·March 10, 2020
BD POSIFLUSH¿ NORMAL SALINE SYRINGE
FDA Adverse Event
Injury
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·October 25, 2022
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·February 22, 2011
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·July 26, 2019
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·July 16, 2019
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·July 29, 2019
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