ClearanceBrief
Company ยท US

Rhythmlink International, LLC

FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2021. Name variants (Inc, Corp, punctuation) are merged.

18510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
GXYElectrode, Cutaneous6
GXZElectrode, Needle5
IKTElectrode, Needle, Diagnostic Electromyograph3
ETNStimulator, Nerve2
FMFSyringe, Piston1
PDQNeurosurgical Nerve Locator1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Feb 9, 2021K203079MR Conditional Sticky Pad Electrode
Rhythmlink International, LLC
GXY
May 27, 2020K200984Guardian Needle Electrode
Rhythmlink International, LLC
GXZ
Aug 5, 2019K191225EEG Electrode Template
Rhythmlink International, LLC
GXY
Jul 10, 2019K190801PressOn Electrode Headset
Rhythmlink International, LLC
GXZ
Dec 1, 2017K172503MR Conditional Cup Electrode, MR Conditional Webb Electrode
Rhythmlink International, LLC
GXY
Apr 11, 2014K132138RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE
Rhythmlink International, LLC
PDQ
Jul 22, 2013K130220MR CONDITIONAL PRESSON ELECTRODE
Rhythmlink International, LLC
GXZ
May 30, 2013K130287MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE
Rhythmlink International, LLC
GXY
Jul 12, 2012K121347PRESSON ELECTRODE
Rhythmlink International, LLC
GXZ
Jun 22, 2012K120342EMG RECORDING ELECTRODE ASSEMBLY
Rhythmlink International, LLC
IKT
Sep 22, 2011K112435RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT
Rhythmlink International, LLC
ETN
Apr 12, 2011K103200PROPEP DELIVERY DEVICE
Rhythmlink International, LLC
FMF
Jun 23, 2009K091056RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252R
Rhythmlink International, LLC
IKT
Jun 23, 2009K091055RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R
Rhythmlink International, LLC
IKT
Jan 22, 2008K072736RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT
Rhythmlink International, LLC
ETN
May 10, 2006K061148RHYTHMLINK DISC ELECTRODES
Rhythmlink International, LLC
GXY
Aug 23, 2005K052188CUTANEOUS ELECTRODE
Rhythmlink International, LLC
GXY
Dec 20, 2002K022914RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES
Rhythmlink International, LLC
GXZ

Latest recalls

DateFirm and productCodeLinked 510(k)
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