13 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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reVive Light Therapy Essentials
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RELION INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·May 4, 2020
SYRINGE 1.0ML 31G 6MM S/C U-100 RELION
FDA Adverse Event
Injury
·BD MEDICAL - DIABETES CARE·Product code FMF·April 6, 2021
A-LINE AEP MONITOR
FDA 510(k)
FDA Class 2
·Neurology
RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·August 12, 2011
ADULT CURL CATH 1CUFF
FDA Adverse Event
Malfunction
·TYCO HEALTHCARE/KENALL·Product code FJS·June 30, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 8, 2013
EA DELTA CER INSERT 36IDX54OD
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code MRA·June 5, 2023
EA DELTA CER INSERT 36IDX54OD
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code LPH·June 1, 2023
XVWEB
FDA Adverse Event
Injury
·PLANET DDS·Product code LLZ·March 13, 2025
SECOND OPINION
FDA Adverse Event
Injury
·PEARL INC.·Product code MYN·March 13, 2025
StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.
FDA Enforcement
Class II
·Ongoing·Stimwave Technologies Inc·September 9, 2020