25 results
·
17ms
·
Sources: EU EUDAMED, US FDA
PRIMA PEDIATRIC GAS SAMPLING CIRCUITS
FDA 510(k)
FDA Class 1
·Anesthesiology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123199·K-WIRE - SINGLE TROCAR THREADED 2.0mm DIA x 150mm
Exit, TCA
FDA UDI
Thermo Fisher Scientific Oy·06438153000143·Exit, TCA is a module of TCAutomation Laborator...
iNSitu™ Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127021602·Lateral Positioning Guide
NON-STERILE POWDER FREE MULTICOLOR - RED, BLUE, PURPLE AND YELLOW LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING
FDA 510(k)
FDA Class 1
·General Hospital
Arthrex Humeral Nails
FDA 510(k)
FDA Class 2
·Orthopedic
NexGen®
FDA UDI
Zimmer, Inc.·00889024207844·
NexGen®
FDA UDI
Zimmer, Inc.·00889024207851·
NexGen®
FDA UDI
Zimmer, Inc.·00889024207868·
NexGen®
FDA UDI
Zimmer, Inc.·00889024259645·
NexGen®
FDA UDI
Zimmer, Inc.·00889024259669·
NexGen®
FDA UDI
Zimmer, Inc.·00889024259676·
NexGen®
FDA UDI
Zimmer, Inc.·00889024259652·
NexGen®
FDA UDI
Zimmer, Inc.·00889024207837·
CR-FLX POR HATCP FEM C-L MINUS CR-FLX POR HATCP FEM C-R MINUS CR-FLX POR HATCP FEM D-L MINUS CR-FLX POR HATCP FEM D-R MINUS CR-FLX POR HATCP FEM E-L MINUS CR-FLX POR HATCP FEM E-R MINUS CR-FLX POR HATCP FEM F-L MINUS CR-FLX POR HATCP FEM F-R MINUS CR-FLX POR HATCP FEM G-L MINUS CR-FLX POR HATCP FEM G-R MINUS This device is indicated for patients with severe knee pain and disability
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 21, 2018
COULTER® ACT DIFF 2 ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC·Product code GKZ·December 7, 2010
CR-FLEX POR HATCP FEM C-L CR-FLEX POR HATCP FEM C-R CR-FLEX POR HATCP FEM D-L CR-FLEX POR HATCP FEM D-R CR-FLEX POR HATCP FEM E-L CR-FLEX POR HATCP FEM E-R CR-FLEX POR HATCP FEM F-L CR-FLEX POR HATCP FEM F-R CR-FLEX POR HATCP FEM G-L CR-FLEX POR HATCP FEM G-R This device is indicated for patients with severe knee pain and disability
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 21, 2018
CR-FLEX POR FEM F-L CR-FLEX POR FEM F-R MINUS CR-FLEX POR FEM G-L This device is indicated for patients with severe knee pain and disability
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 21, 2018
BAERVELDT SHUNT
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code KYF·May 10, 2016
LEAD STYLET KIT
FDA Adverse Event
Malfunction
·RICE CREEK MFG·Product code DRB·February 9, 2013