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
2641–2664 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Mar 27, 2008
MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
K061907 · OLW
Ge Healthcare
Neurology · 631d
Cleared Mar 13, 2008
AEMED STIMPAD ACU-TENS TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL 021999
K071120 · GZJ
Aemed, Inc.
Neurology · 328d
Cleared Mar 11, 2008
KFH ENERGY, MODEL: E1
K073008 · GZJ
Kingfisher Healthcare NV
Neurology · 139d
Cleared Mar 07, 2008
TENS/IF 14
K071869 · GZJ
Emsi
Neurology · 245d
Cleared Mar 04, 2008
BAXANO ULTRA LOW PROFILE RONGEUR
K080494 · HAE
Baxano, Inc.
Neurology · 11d
Cleared Feb 28, 2008
LIMITED ARTIFACT SKULL PIN, MODEL 0107
K073163 · HBL
Dinkler Surgical Devices, Inc.
Neurology · 111d
Cleared Feb 28, 2008
SMART COUPLER, MODEL M015401
K073384 · GWJ
Intelligent Hearing Systems
Neurology · 87d
Cleared Feb 28, 2008
EEG NEUROAMP, MODEL CS10137
K073557 · HCC
Corscience GmbH & Co. KG
Neurology · 71d
Cleared Feb 28, 2008
MODIFICATION TO:NESS L300
K080219 · GZI
Ness-Neuromuscular Electrical...
Neurology · 30d
Cleared Feb 26, 2008
MICRUS MICROCOIL SYSTEMS
K073442 · HCG
Micrus Endovascular Corporation
Neurology · 81d
Cleared Feb 22, 2008
NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES
K073576 · HBA
Harod Enterprises, Inc.
Neurology · 65d
Cleared Feb 15, 2008
MODEL I-2000 MONITOR
K072382 · OLT
Infinite Biomedical Technologies
Neurology · 175d
Cleared Feb 14, 2008
FACTS HAND AND PINCH GRIP COMBO
K073154 · LBB
Global Services Group, LLC
Neurology · 98d
Cleared Feb 14, 2008
PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA...
K073419 · HCG
Rj Medical, Inc.
Neurology · 71d
Cleared Feb 07, 2008
PROSTIM 1000/2000
K073438 · GZJ
Bio Protech, Inc.
Neurology · 62d
Cleared Feb 06, 2008
ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0
K072899 · HAW
Aesculap Implant Systems, Inc.
Neurology · 118d
Cleared Feb 05, 2008
VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM
K072254 · GWN
Interacoustics A/S
Neurology · 175d
Cleared Feb 05, 2008
BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM
K073626 · GWJ
Bio-Logic Systems Corp.
Neurology · 41d
Cleared Feb 01, 2008
NTRAINER SYSTEM
K071866 · HCC
Kcbiomedix, Inc.
Neurology · 210d
Cleared Feb 01, 2008
HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE
K072123 · GZJ
Biowave Corporation
Neurology · 183d
Cleared Jan 30, 2008
SMALL LUMEN PERITONEAL CATHETER
K073139 · JXG
Medtronic Neurosurgery
Neurology · 84d
Cleared Jan 25, 2008
ALGO 5 NEWBORN HEARING SCREENER
K073665 · GWJ
Natus Medical, Inc.
Neurology · 30d
Cleared Jan 24, 2008
MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS)
K072806 · HAW
Mako Surgical Corp.
Neurology · 115d
Cleared Jan 22, 2008
BOSTON-BAND CRANIAL REMODLING ORTHOSIS
K072862 · OAN
Boston Brace Intl., Inc.
Neurology · 109d