15 results
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30ms
·
Sources: EU EUDAMED, US FDA
NERBRIDGE
FDA 510(k)
FDA Class 2
·Neurology
AGC KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304242968·
Endo-Model Modular Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575302864·Femoral Segment
Endo-Model Modular Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575302871·Femoral Segment
PMMA CAD/CAM DISC
FDA 510(k)
FDA Class 2
·Dental
SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2
FDA 510(k)
FDA Class 2
·Neurology
UNK PERCLOSE
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·April 22, 2024
PROPLEGE CORONARY SINUS CATHETER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DWF·October 8, 2014
VIVA S
FDA Adverse Event
Malfunction
·IPG MFG SWITZERLAND·Product code NIK·June 8, 2013
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DRY·June 17, 2011
ELAN 4 MIS SLEEVE F/1-RING HANDPIECES
FDA Adverse Event
Injury
·AESCULAP AG·Product code HBC·October 28, 2018
ELAN 4 ELECTRO MOTOR CABLE W/HAND SWITCHHIGH SPEED POWER SYSTEMS
FDA Adverse Event
Malfunction
·AESCULAP AG·Product code HBC·November 5, 2018
HARMONIC ACE 5MM SHEAR
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·February 3, 2020
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
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