Medical Device Manufacturer · US , Walker , MI

Cadwell Laboratories, Inc.

46 submissions · 46 cleared · Since 1979
46
Total
46
Cleared
0
Denied

Cadwell Laboratories, Inc. — FDA 510(k) Submissions

Cadwell Laboratories, Inc. has submitted 46 FDA 510(k) premarket notifications since 1979, of which 46 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Stimulator, Electrical, Evoked Response, Electrode, Cutaneous, Full-montage Standard Electroencephalograph, Electrode, Needle, Media, Electroconductive . Use the specialty filter in the sidebar to narrow results.

46 devices
1–25 of 46
CADWELL EASYNET OXIMETER MODULE
K061706 · DQA Oximeter · Anesthesiology
Mar 2007 262d
CADWELL EASYNET NASAL PRESSURE MODULE
K061705 · MNR Ventilatory Effort Recorder · Anesthesiology
Nov 2006 158d
TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR
K042350 · GWF Stimulator, Electrical,... · Neurology
Nov 2004 65d
EASYNET BODY POSITION MODULE
K040932 · LEL Device, Sleep Assessment · Neurology
Jul 2004 83d
CADWELL LIMB MOVEMENT MODULE
K040986 · LEL Device, Sleep Assessment · Neurology
Jul 2004 77d
KILOWIN
K971214 · GWE Stimulator, Photic,... · Neurology
Jun 1998 435d
FOUR-CHANNEL PREAMPLIFIER
K962455 · GWF Stimulator, Electrical,... · Neurology
Jan 1997 202d
TWO-CHANNEL PREAMPLIFIER
K962457 · GWF Stimulator, Electrical,... · Neurology
Jan 1997 202d
CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER
K962458 · GWF Stimulator, Electrical,... · Neurology
Jan 1997 202d
CADWELL EASY AMBULATORY EEG
K946094 · GWQ Full-montage Standard... · Neurology
Sep 1995 272d
EEG NEEDLE ELECTRODE
K933796 · GXZ Electrode, Needle · Neurology
Dec 1994 512d
EEG CUP ELECTRODE
K933808 · GXY Electrode, Cutaneous · Neurology
Dec 1994 512d
RING ELECTRODE
K933805 · GXY Electrode, Cutaneous · Neurology
Dec 1994 502d
ELECTRODE, CUTANEOUS
K933801 · GXY Electrode, Cutaneous · Neurology
Oct 1994 443d
CUTANEOUS ELECTRODE
K933802 · GXY Electrode, Cutaneous · Neurology
Sep 1994 399d
GROUND PLATE ELECTRODE
K933807 · GXY Electrode, Cutaneous · Neurology
Jul 1994 356d
DISPOSABLE TAB ELECTRODE
K933803 · GXY Electrode, Cutaneous · Neurology
Jul 1994 338d
TEN-20 CONDUCTIVE PASTE GEL
K933799 · GYB Media, Electroconductive · Neurology
May 1994 296d
OMNI PREP GEL
K933797 · GYB Media, Electroconductive · Neurology
May 1994 286d
CONCENTRIC EMG NEEDLE ELECTRODE
K933795 · GXZ Electrode, Needle · Neurology
Apr 1994 261d
NU-PREP GEL
K933798 · GXB Esthesiometer · Neurology
Apr 1994 261d
MONOPOLAR EMG NEEDLE ELECTRODE
K933806 · GXZ Electrode, Needle · Neurology
Apr 1994 261d
GROUND/REFERENCE NEEDLE ELECTRODE
K933793 · GXZ Electrode, Needle · Neurology
Apr 1994 258d
CADWELL EASY WRITER AND EASY READER
K932407 · GWQ Full-montage Standard... · Neurology
Mar 1994 308d
LECTRON II CONDUCTIVE GEL/CADWELL ELECTRODE GEL
K933804 · GYB Media, Electroconductive · Neurology
Mar 1994 230d
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