46 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Syringe Holder accessory
FDA 510(k)
FDA Unclassified
·Unknown
Navajo Tribal Utility Authority - 18 Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588012780·Navajo Tribal Utility Authority - 18 Metal
24 HOLE INFILTRATION
FDA UDI
The Wells Johnson Company·B458201248000·Cannula, 24-Hole Infiltration, specify length, ...
MULTI-PULSE 2000
FDA 510(k)
FDA Class 2
·Dental
ICASE
FDA 510(k)
FDA Class 2
·Ophthalmic
StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - 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
SWAN-GANZ VIP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DYG·February 26, 2026
SWAN-GANZ VIP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DYG·April 1, 2026
SWAN-GANZ VIP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DYG·April 1, 2026
SWAN-GANZ VIP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DYG·April 12, 2026
SWAN-GANZ VIP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DYG·August 13, 2025
SWAN-GANZ VIP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DYG·April 1, 2026
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 27, 2014
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·July 29, 2011
VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAM·July 2, 2013
ACCU-CHEK SPIRIT CARTRIDGE
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·January 13, 2009
SWAN-GANZ VIP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DYG·November 26, 2025
SWAN-GANZ VIP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DYG·August 20, 2025
SWAN-GANZ VIP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DYG·April 10, 2026
SWAN-GANZ VIP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DYG·April 11, 2026