Panels › Ear, Nose, Throat › Product code ETN · Class 2
Stimulator, Nerve
Regulation 874.1820
2510(k)s in 12 months (97 all time)
0recalls in 12 months (31 all time)
29recalls that name a 510(k)
Top companies in ETN
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Xomed | 10 | 9 |
| Neurovision Medical Products, Inc. | 5 | 12 |
| The Magstim Company , Ltd. | 9 | 1 |
| Nuvasive, Inc. | 6 | 0 |
| Inomed Medizintechnik GmbH | 5 | 0 |
| Rln Systems, Inc. | 5 | 0 |
| Spes Medica Srl | 2 | 3 |
| Baxano, Inc. | 3 | 0 |
| Checkpoint Surgical | 1 | 2 |
| Ndi Medical, LLC | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 12, 2006 | K061365 | CHECKPOINT WITH ACCUSTIM TECHNOLOGY Ndi Medical, LLC | ETN |
| Dec 14, 2005 | K053141 | NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800 The Magstim Company , Ltd., GB | ETN |
| Sep 15, 2005 | K051718 | NUVASIVE NEUROVISION JJB SYSTEM Nuvasive, Inc. | ETN |
| Mar 3, 2005 | K050162 | CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE Medtronic Xomed, Inc. | ETN |
| Apr 1, 2004 | K040543 | NUVASIVE NEUROVISION JJB SYSTEM Nuvasive, Inc. | ETN |
| Oct 24, 2003 | K032083 | NUVASIVE NEUROVISION JJB SYSTEM Nuvasive, Inc. | ETN |
| Jun 18, 2003 | K031510 | NIM-SPINE Medtronic Xomed | ETN |
| Apr 11, 2003 | K031003 | STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES Medtronic Xomed, Inc. | ETN |
| Oct 24, 2002 | K021595 | GYRUS ENT NERVE STIMULATOR Gyrus Ent LLC | ETN |
| Apr 17, 2002 | K020955 | NICOLET ELECTROCAUTERY DETECTOR Nicolet Biomedical, Inc. | ETN |
| Jan 22, 2002 | K014165 | STIMULUS - DISSECTION INSTRUMENTS Medtronic Xomed, Inc. | ETN |
| Apr 20, 2001 | K010213 | MODIFICATION TO CAVERMAP SURGICAL AID Uromed Corp. | ETN |
| Jan 16, 2001 | K003745 | LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET Rln Systems, Inc. | ETN |
| Apr 21, 2000 | K000507 | CAVERMAP SURGICAL AID Uromed Corp. | ETN |
| Oct 7, 1999 | K992869 | XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE Xomed, Inc. | ETN |
| May 19, 1999 | K991583 | NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR The Magstim Company , Ltd. | ETN |
| Sep 4, 1998 | K982595 | NIM4 Xomed, Inc. | ETN |
| Aug 5, 1998 | K980148 | NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR The Magstim Company , Ltd., GB | ETN |
| Oct 27, 1997 | K970971 | URO MED NERVE STIMULATOR Uromed Corp. | ETN |
| Jun 6, 1997 | K971143 | NEURO PULSE II,III Aaron Medical Industries | ETN |
| May 14, 1997 | K964869 | NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR The Magstim Company , Ltd., GB | ETN |
| Dec 22, 1995 | K954601 | NERVE LOCATOR/MONITOR SYSTEM MODIFICATION Rln Systems, Inc. | ETN |
| Jun 2, 1995 | K945799 | NEUROSIGN 100 IMPEDANCE METER The Magstim Company , Ltd., GB | ETN |
| May 9, 1995 | K951641 | NEUROSCREEN SOFTWARE FOR USE WITH THE NEUROSIGN 100 NERVE MONITOR The Magstim Company , Ltd., GB | ETN |
| Dec 27, 1994 | K945242 | NERVE MONITOR ELECTRODES/STIMULATOR PROBES Micromed Development Corp. | ETN |
| Jul 20, 1994 | K934733 | STIMULATING SURGICAL INSTRUMENTS Smith & Nephew Richards, Inc. | ETN |
| May 13, 1994 | K934426 | NERVE INTEGRITY MONITOR-2 (NIM-2 XL) Xomed-Treace, Inc. | ETN |
| Nov 19, 1993 | K933491 | R AND D BATTERIES, INC. PART NOS. 5038 & 5347 R & D Batteries, Inc. | ETN |
| Aug 17, 1993 | K925640 | XOMED-TREACE EMG ENDOTRACHEAL TUBEEN Xomed-Treace, Inc. | ETN |
| Nov 24, 1992 | K925008 | RLN NERVE LOCATOR/MONITOR; MODEL A Rln Systems, Inc. | ETN |
| Nov 24, 1992 | K923056 | NEUROSIGN MODEL 100 The Magstim Company , Ltd., GB | ETN |
| Sep 30, 1992 | K912508 | NERVE LOCATOR/MONITOR SYSTEM, MODIFICATION Rln Systems, Inc. | ETN |
| Apr 19, 1991 | K905035 | AXOSTIM NERVE STIMULATOR, MODIFICATION Singer Medical Products, Inc. | ETN |
| Mar 15, 1991 | K905045 | NERVE LOCATOR/STIMULATOR Aaron Medical Industries | ETN |
| Mar 27, 1990 | K895838 | BRACKMANN EMG MONITORING SYSTEM Wr Medical Electronics Co. | ETN |
| Mar 27, 1990 | K894930 | DENTEC 4000 Dentec, Inc. | ETN |
| Dec 8, 1989 | K895676 | HEMOSTAT/STIMULATOR PROBE Rln Systems, Inc. | ETN |
| Jul 15, 1988 | K881757 | RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS Downs Surgical , Ltd. | ETN |
| Jun 1, 1988 | K874018 | NEUROPROBE Inovx, Inc. | ETN |
| May 20, 1988 | K880720 | MONTGOMERY NERVE STIMULATOR Boston Medical Products, Inc. | ETN |
| Nov 20, 1987 | K873964 | NICOLET DISPOSABLE PRASS PROBE Nicolet Biomedical Instruments | ETN |
| Oct 20, 1987 | K872791 | POREX NERVE LOCATOR Porex Medical | ETN |
| Aug 5, 1987 | K870272 | MODEL 6110C OTOPHOR Life-Tech Intl., Inc. | ETN |
| May 21, 1985 | K843226 | EVOKED RESPONSE ELECTRICAL STIMULATOR Nucleus, Ltd. | ETN |
| Feb 10, 1984 | K833646 | PULSATRON NERVE LOCATOR/STIMULATOR Edward Weck, Inc. | ETN |
| Jul 7, 1983 | K831715 | NEUROTRAC Hdc Corp. | ETN |
| Dec 7, 1978 | K781569 | NERVE LOCATER/STIMULATOR Intermedics, Inc. | ETN |
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