FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Neurology ×
6,291 results
3673–3696 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Mar 19, 2001
XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP
K010087 · GWF
Excel Tech. , Ltd.
Neurology · 67d
Cleared Mar 16, 2001
REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128-RP
K010084 · GWQ
Excel Tech. , Ltd.
Neurology · 64d
Cleared Mar 15, 2001
YORAMED, MODEL T-202
K002297 · GZJ
United Yoram Distributors, Inc.
Neurology · 230d
Cleared Mar 15, 2001
EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED)
K010085 · OMB
Excel Tech. , Ltd.
Neurology · 63d
Cleared Mar 15, 2001
LORENZ FIDUCAIL SCREW
K010427 · HAW
Walter Lorenz Surgical, Inc.
Neurology · 30d
Cleared Mar 13, 2001
MEMOGRAPH
K001353 · HBW
Biomedical Ent., Inc.
Neurology · 319d
Cleared Mar 12, 2001
MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
K010548 · HAW
Radionics, A Division of Tyco...
Neurology · 14d
Cleared Mar 08, 2001
LIFECARE COMPACT TENS DEVICE
K003369 · GZJ
Lifecare , Ltd.
Neurology · 129d
Cleared Feb 27, 2001
MEDIVISION IGS SYSTEM
K003699 · HAW
Medivision (U.S.A.), Inc.
Neurology · 88d
Cleared Feb 27, 2001
ENGPLUS
K010059 · GWN
Western Systems Research, Inc.
Neurology · 50d
Cleared Feb 23, 2001
ORTHOPILOT
K003347 · HAW
Kinamed, Inc.
Neurology · 121d
Cleared Feb 23, 2001
MICROTARGETING DRIVE SYSTEM
K003776 · HAW
FHC, Inc.
Neurology · 78d
Cleared Feb 22, 2001
Z-TOUCH
K003268 · HAW
Brainlab AG
Neurology · 127d
Cleared Feb 22, 2001
MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES
K003914 · GWG
Medtronic PS Medical
Neurology · 65d
Cleared Feb 21, 2001
MEDRELIEF
K003507 · GZJ
Healthonics, Inc.
Neurology · 100d
Cleared Feb 20, 2001
MICROSPEED EC MOTORSYSTEM GD650/GD653
K003612 · HBC
Aesculap, Inc.
Neurology · 90d
Cleared Feb 14, 2001
TENSCARE, MODEL TENS XL-2
K003591 · GZJ
Tenscare, Ltd.
Neurology · 85d
Cleared Feb 09, 2001
REMVIEW SLEEP RECORDER, MODEL 320
K003499 · LEL
Respironics, Inc.
Neurology · 88d
Cleared Feb 09, 2001
64 CHANNEL EEG / MODEL NUMBER EX-NW-64
K010150 · GWQ
Excel Tech. , Ltd.
Neurology · 23d
Cleared Feb 05, 2001
CURRY MULTIMODAL NEUROIMAGING SOFTWARE
K001781 · OLX
Neurosoft, Inc.
Neurology · 237d
Cleared Feb 05, 2001
MULTI INTERFERENTIAL STIMULATOR, MODEL TR-841
K993600 · LIH
Nisha Communication Industries
Neurology · 469d
Cleared Feb 02, 2001
WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE
K002219 · GXY
Wandy Rubber Industrial Co., Ltd.
Neurology · 193d
Cleared Feb 02, 2001
WANDY SILICONE CONDUCTIVE RUBBER PAD
K002227 · GXY
Wandy Rubber Industrial Co., Ltd.
Neurology · 193d
Cleared Feb 02, 2001
ANALGESIC PULSER, MODEL AP-439
K993229 · GZJ
Johari Electro-Tech Co.
Neurology · 494d