18 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ArgenZ HT+ 95x30 D2
FDA UDI
ARGEN CORPORATION, THE·D818122822·Dental porcelain/ceramic restoration kit
IMPLANT-ONE SYSTEM
FDA 510(k)
FDA Class 2
·Dental
SLEEPSTRIP II
FDA 510(k)
FDA Class 2
·Anesthesiology
BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON AND CO.·Product code FMI·March 16, 2019
PN 31X8 100 PK GERMANY
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·March 29, 2019
BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·January 28, 2019
BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·February 22, 2019
BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·April 16, 2019
POLARIS X?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SAN JOSE·Product code DRF·May 21, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 18, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 14, 2011
PERITX DRAINAGE BAG
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·April 3, 2026
FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
FDA Enforcement
Class III
·Terminated·Bio-Rad Laboratories·October 30, 2013
PERITX DRAINAGE BAG KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·December 18, 2025
PERITX DRAINAGE BAG
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·April 11, 2026
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·November 25, 2024
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015