Company ยท US
Cadwell Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 2007. Name variants (Inc, Corp, punctuation) are merged.
46510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GWF | Stimulator, Electrical, Evoked Response | 12 |
| GXY | Electrode, Cutaneous | 7 |
| GWQ | Full-Montage Standard Electroencephalograph | 4 |
| GXZ | Electrode, Needle | 4 |
| GYB | Media, Electroconductive | 3 |
| GWE | Stimulator, Photic, Evoked Response | 2 |
| GWJ | Stimulator, Auditory, Evoked Response | 2 |
| HLX | Photostimulator, Ac-Powered | 2 |
| IKN | Electromyograph, Diagnostic | 2 |
| LEL | Device, Sleep Assessment | 2 |
| DQA | Oximeter | 1 |
| GXB | Esthesiometer | 1 |
| GYA | Tester, Electrode/Lead, Electroencephalograph | 1 |
| HLZ | Electrode, Corneal | 1 |
| JXE | Device, Nerve Conduction Velocity Measurement | 1 |
| MNR | Ventilatory Effort Recorder | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 5, 2007 | K061706 | CADWELL EASYNET OXIMETER MODULE Cadwell Laboratories, Inc. | DQA |
| Nov 21, 2006 | K061705 | CADWELL EASYNET NASAL PRESSURE MODULE Cadwell Laboratories, Inc. | MNR |
| Nov 3, 2004 | K042350 | TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR Cadwell Laboratories, Inc. | GWF |
| Jul 1, 2004 | K040986 | CADWELL LIMB MOVEMENT MODULE Cadwell Laboratories, Inc. | LEL |
| Jul 1, 2004 | K040932 | EASYNET BODY POSITION MODULE Cadwell Laboratories, Inc. | LEL |
| Jun 11, 1998 | K971214 | KILOWIN Cadwell Laboratories, Inc. | GWE |
| Jan 13, 1997 | K962458 | CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER Cadwell Laboratories, Inc. | GWF |
| Jan 13, 1997 | K962457 | TWO-CHANNEL PREAMPLIFIER Cadwell Laboratories, Inc. | GWF |
| Jan 13, 1997 | K962455 | FOUR-CHANNEL PREAMPLIFIER Cadwell Laboratories, Inc. | GWF |
| Sep 12, 1995 | K946094 | CADWELL EASY AMBULATORY EEG Cadwell Laboratories, Inc. | GWQ |
| Dec 29, 1994 | K933808 | EEG CUP ELECTRODE Cadwell Laboratories, Inc. | GXY |
| Dec 29, 1994 | K933796 | EEG NEEDLE ELECTRODE Cadwell Laboratories, Inc. | GXZ |
| Dec 19, 1994 | K933805 | RING ELECTRODE Cadwell Laboratories, Inc. | GXY |
| Oct 21, 1994 | K933801 | ELECTRODE, CUTANEOUS Cadwell Laboratories, Inc. | GXY |
| Sep 7, 1994 | K933802 | CUTANEOUS ELECTRODE Cadwell Laboratories, Inc. | GXY |
| Jul 26, 1994 | K933807 | GROUND PLATE ELECTRODE Cadwell Laboratories, Inc. | GXY |
| Jul 8, 1994 | K933803 | DISPOSABLE TAB ELECTRODE Cadwell Laboratories, Inc. | GXY |
| May 27, 1994 | K933799 | TEN-20 CONDUCTIVE PASTE GEL Cadwell Laboratories, Inc. | GYB |
| May 17, 1994 | K933797 | OMNI PREP GEL Cadwell Laboratories, Inc. | GYB |
| Apr 22, 1994 | K933806 | MONOPOLAR EMG NEEDLE ELECTRODE Cadwell Laboratories, Inc. | GXZ |
| Apr 22, 1994 | K933798 | NU-PREP GEL Cadwell Laboratories, Inc. | GXB |
| Apr 22, 1994 | K933795 | CONCENTRIC EMG NEEDLE ELECTRODE Cadwell Laboratories, Inc. | GXZ |
| Apr 19, 1994 | K933793 | GROUND/REFERENCE NEEDLE ELECTRODE Cadwell Laboratories, Inc. | GXZ |
| Mar 22, 1994 | K933804 | LECTRON II CONDUCTIVE GEL/CADWELL ELECTRODE GEL Cadwell Laboratories, Inc. | GYB |
| Mar 22, 1994 | K932407 | CADWELL EASY WRITER AND EASY READER Cadwell Laboratories, Inc. | GWQ |
| Jun 22, 1993 | K931428 | CADWELL 6200 A Cadwell Laboratories, Inc. | GWF |
| Mar 23, 1993 | K924723 | CADWELL SIERRA Cadwell Laboratories, Inc. | GWF |
| Sep 18, 1991 | K905059 | HIGH SPEED MAGNETIC STIMULATOR Cadwell Laboratories, Inc. | GWF |
| Nov 9, 1989 | K895081 | PROMONTORY STIMULATING ELECTRODE Cadwell Laboratories, Inc. | GXY |
| Sep 29, 1989 | K894276 | CADWELL FREEDOM EEG DEVICE Cadwell Laboratories, Inc. | GWQ |
| May 4, 1988 | K880088 | CADWELL EXCEL Cadwell Laboratories, Inc. | GWF |
| Jul 21, 1987 | K872183 | AMBULATORY EEG PLAYBACK Cadwell Laboratories, Inc. | GWQ |
| Jan 13, 1987 | K863175 | EES 10 ELECTRODELESS ELECTRICAL STIMULATOR Cadwell Laboratories, Inc. | GWF |
| Nov 18, 1986 | K860801 | MODEL 8400 W/MODIFICATIONS (SPECTRUM 32) Cadwell Laboratories, Inc. | GWE |
| Sep 17, 1986 | K862363 | INSERT EARPHONES Cadwell Laboratories, Inc. | GWJ |
| Sep 17, 1986 | K862361 | 40-HZ AUDITORY EVOKED RESPONSE TEST Cadwell Laboratories, Inc. | GWJ |
| May 21, 1985 | K844707 | QUANTUM 84 Cadwell Laboratories, Inc. | GWF |
| May 16, 1983 | K831231 | LED GOGGLES Cadwell Laboratories, Inc. | HLX |
| Apr 28, 1983 | K830770 | CONTRAST SENSITIVITY EQUIPMENT Cadwell Laboratories, Inc. | HLX |
| Apr 12, 1983 | K830771 | CADWELL 8400 Cadwell Laboratories, Inc. | GWF |
| Sep 24, 1982 | K822214 | CADWELL 7400 Cadwell Laboratories, Inc. | GWF |
| Apr 9, 1982 | K820254 | GOLD FOIL ERG ELECTRODES Cadwell Laboratories, Inc. | HLZ |
| Feb 4, 1982 | K820031 | CADWELL 5200 Cadwell Laboratories, Inc. | JXE |
| Jan 28, 1982 | K820040 | SC-IT IMPEDANCE TESTER Cadwell Laboratories, Inc. | GYA |
| Apr 21, 1980 | K800648 | CADWELL 7200 Cadwell Laboratories, Inc. | IKN |
| Aug 16, 1979 | K791235 | CADWELL 7000 ELECTROMYOGRAPH MACHINE Cadwell Laboratories, Inc. | IKN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||