10 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES
FDA 510(k)
FDA Class 2
·Orthopedic
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776365264·Exodontia Oral Gauze Packer # 2
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036027629·
DATEX-OHMEDA INOVENT DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 2, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 15, 2014
BD VACUTAINER BRAND NEEDLES
FDA Adverse Event
Injury
·BD·Product code JKA·May 6, 2011
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012
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