15 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
GLIDE DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102275·DALK CORNEAL DISSECTOR
Freedom Pedicle Screw System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215027292·
G7 DUAL MOBILITY LINER 46MM G
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·May 3, 2017
SUNMAX VIETNAM CO. LTD POWDER FREE WHITE NITRILE EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·October 1, 2014
INTERLOCK?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KRD·May 29, 2013
ADAPTA DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NVZ·June 16, 2011
G7 ACETABULAR LINER
FDA Adverse Event
Malfunction
·BIOMET ORTHOPEDICS·Product code PBI·May 3, 2017
INTELLIVUE MX500 PATIENT MONITOR
FDA Adverse Event
Death
·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·December 4, 2023
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code FDS·July 22, 2022
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
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
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020