162 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
TI-MAX X450
FDA 510(k)
FDA Class 1
·Dental
NSK
FDA Adverse Event
Malfunction
·NAKANISHI INC.·Product code EFB·December 6, 2018
NSK
FDA Adverse Event
Malfunction
·NAKANISHI INC.·Product code EFB·December 6, 2018
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·February 11, 2020
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017712·K-Wire, Double Ended, Trocar Point, Diameter Si...
n/a
FDA UDI
HANS RUDOLPH, INC.·00874750006021·SALIVA COLLECTOR MPORT LG 6985
MEGA PLUS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809155852340·Rod, Ø6.0 x 240mm
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0120240·Screwdriver, Extended Tab, Cannulated, SNI 1, L...
IMPACT RIMLOC HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304221055·
RPM RESPIRATORY GATING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
EBI XFIX DFS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BD CONVENTIONAL SYRINGE 50ML
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·March 14, 2022
CASPIAN Spinal System
FDA UDI
VB Spine LLC·10888857242098·Rod Bender
AFFINITY THREE BIRTHING BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code HDD·May 2, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 2, 2011
ENCORE FEMORAL HEAD COMPONENTS
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWY·August 14, 2008
MEDTRONIC TRANSCATHETER VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·April 17, 2025
DeRoyal NEURO PACK, REF 89-10682.02
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
QMS Tacrolimus Calibrators, Product code 10015573
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·January 17, 2024
Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile EO. Microtek Medical, Inc., Columbus, MS 39702.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 14, 2016