46 results · 23ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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