ClearanceBrief
Panels › Anesthesiology › Product code KOI · Class 2

Stimulator, Nerve, Peripheral, Electric

Regulation 868.2775

1510(k)s in 12 months (29 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
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Top companies in KOI

Company510(k)sRecalls
Nihon Kohden Corporation30
Organon Teknika Corp.30
Senzime AB30
Blink Device Company20
GE Healthcare11
Idmed20
Life-Tech Intl., Inc.20
MIPM Mammendorfer Institut für Physik und Medizin GmbH20
Biometer Intl. A/S10
Datex Division Instrumentarium Corp.10
Decided510(k)Device and applicantCode
May 22, 2026K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)Te
Senzime AB, SE
KOI
Oct 21, 2025K250887Neuromuscular Transmission Monitor TOF3D (2510091)
MIPM Mammendorfer Institut für Physik und Medizin GmbH, DE
KOI
Jun 23, 2025K243339WiTOF
Idmed, FR
KOI
Dec 5, 2024K242525iTOF®
Nerbio Medical Software Platforms, Inc.
KOI
Aug 17, 2022K220530Tetragraph Neuromuscular Transmission Monitor
Senzime AB, SE
KOI
Jul 21, 2022K220976Life Scope PT BSM-1700 Series Bedside Monitor
Nihon Kohden Corporation, JP
KOI
May 5, 2022K212434Neuromuscular Transmission Monitor TOF3D
MIPM Mammendorfer Institut für Physik und Medizin GmbH, DE
KOI
Dec 29, 2021K213316Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, N
Nihon Kohden Corporation, JP
KOI
May 2, 2021K201949Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series
Nihon Kohden Corporation, JP
KOI
Apr 2, 2020K192958TwitchView System
Blink Device Company
KOI
Oct 18, 2019K190795Tetragraph Neuromuscular Transmission Monitor
Senzime AB, SE
KOI
May 31, 2018K172690ToFscan
Idmed, FR
KOI
Mar 29, 2018K172843TwitchView System
Blink Device Corporation
KOI
Dec 5, 2016K162048EZstim*III Peripheral Nerve Stimulator/Nerve Locator
Halyard Health - Irvine
KOI
Jul 15, 2005K051635DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES
GE Healthcare
KOI
Sep 1, 2004K042003INFINITY TRIDENT NMT POD
Draeger Medical Systems, Inc.
KOI
Mar 2, 2004K023342NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE MAPPING PROBE, NEURO-TRACE III NERVE BG
Hdc Corp.
KOI
Apr 6, 2001K002889PNS MAGNETIC STIMULATOR SYSTEM
Neotonus, Inc.
KOI
Aug 30, 1999K992598TOF-WATCH SX
Organon Teknika Corp.
KOI
Aug 30, 1999K992596TOF-WATCH S
Organon Teknika Corp.
KOI
Dec 16, 1997K972698TOF-WATCH
Organon Teknika Corp.
KOI
Apr 28, 1997K955026AS/3 NMT MODULE
Datex Medical Instrumentation, Inc.
KOI
Dec 10, 1996K955031MAXISTIM
Life-Tech Intl., Inc.
KOI
Dec 10, 1996K954505EZ STIM
Life-Tech Intl., Inc.
KOI
May 23, 1996K953205CONSTANT CURRENT PERIPHERAL NERVE STIMULATOR NS272 (MODIFICATION)
Fisher & Paykel Healthcare, Ltd., NZ
KOI
Sep 1, 1993K925159TOF-GUARD TRANSMISSION MONITOR
Biometer Intl. A/S, DK
KOI
May 27, 1993K924234CONS. CURRENT PERIPH. NERVE LOC. NS232,NS262,NS272
Fisher & Paykel Electronics , Ltd., NZ
KOI
Jun 2, 1986K861091EASISTIM
Promed Corp.
KOI
Feb 17, 1984K840108NEUROMUSCULAR TRANSMISSION MONITOR
Datex Division Instrumentarium Corp.
KOI

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