15 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
Eberle Shaver Blades
FDA UDI
Eberle GmbH & Co. KG·04050052015817·Round Burr 4,2
RECAP/MAGNUM HIP INSTRUMENTATION
FDA UDI
Biomet Uk Ltd·05019279108169·
UniTip Catheter
FDA UDI
Unisensor AG·07640172971406·
BLADEVIEW
FDA 510(k)
FDA Class 2
·Radiology
SPLIT SEPTUM INJECTION SITES
FDA 510(k)
FDA Class 2
·General Hospital
Trilogy®
FDA UDI
Zimmer, Inc.·00889024569508·
Trilogy®
FDA UDI
Zimmer, Inc.·00889024638075·
Trilogy®
FDA UDI
Zimmer, Inc.·00889024638068·
Trilogy®
FDA UDI
Zimmer, Inc.·00889024569492·
CONSERVE(R) TOTAL A-CLASS HEAD
FDA Adverse Event
Injury
·MICROPORT ORTHOPEDICS INC.·Product code JDL·October 3, 2014
NEXGEN LCCK ART SURFACE WITH LOCKING SCREW
FDA Adverse Event
Injury
·ZIMMER INC.·Product code JWH·June 21, 2011
LOCKING TITANIUM ADAPTER
FDA Adverse Event
Malfunction
·KANAE CO.,LTD.·Product code KDJ·June 3, 2013
Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 28, 2025
C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·September 24, 2014