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
2425–2448 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Apr 15, 2010
LASERTOUCHONE (OTC)
K100116 · NUH
Laser Health Technologies, LLC
Neurology · 90d
Cleared Apr 14, 2010
SYNTHES AIR PEN DRIVE (APD) SYSTEM
K093361 · HBB
Synthes (Usa)
Neurology · 168d
Cleared Apr 09, 2010
NEUROLINK IP MODEL: PK1117
K100683 · GWQ
Natus Medical Incorporated
Neurology · 30d
Cleared Apr 02, 2010
ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01
K091933 · BWK
Inno-Health Technology, Inc.
Neurology · 276d
Cleared Mar 31, 2010
IMNS MEDACTA NAVIGATION SYSTEM,33.221000US
K100314 · HAW
Medacta International S.A.
Neurology · 55d
Cleared Mar 30, 2010
HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2
K092448 · GZJ
Hivox Biotek, Inc.
Neurology · 232d
Cleared Mar 26, 2010
MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION
K091940 · GWF
Tonica Elektronik A/S
Neurology · 269d
Cleared Mar 18, 2010
NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800
K092699 · GWL
Neurotronics, Inc.
Neurology · 197d
Cleared Mar 10, 2010
FIXIT HEADREST CLAMP SYSTEM
K083803 · HBL
Medicon EG
Neurology · 443d
Cleared Mar 03, 2010
GRINDCARE
K092675 · HCC
Medotech A/S
Neurology · 183d
Cleared Feb 22, 2010
NATUS NEUROWORKS, MODEL 104196
K090019 · OMB
Natus Medical, Inc.
Neurology · 416d
Cleared Feb 17, 2010
JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS
K092227 · HAE
Integra Lifesciences Corp.
Neurology · 209d
Cleared Feb 12, 2010
WAYPOINT STEREOTACTIC SYSTEM
K092192 · HAW
FHC, Inc.
Neurology · 206d
Cleared Feb 05, 2010
OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407
K091757 · NUH
Well-Life Healthcare Limited
Neurology · 234d
Cleared Feb 04, 2010
TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM
K093142 · HCG
Boston Scientific Corp
Neurology · 122d
Cleared Jan 29, 2010
STATNET, MODEL 3100
K092828 · GXY
Hydrodot, Inc.
Neurology · 137d
Cleared Jan 22, 2010
SIPHONX GRAVITATIONAL ANTISIPHON DEVICE
K091328 · JXG
Sophysa SA
Neurology · 262d
Cleared Jan 22, 2010
OWL UNIVERSAL RF SYSTEM URF-3AP (ML)
K093185 · GXD
Diros Technology, Inc.
Neurology · 105d
Cleared Jan 22, 2010
OSV II LOW FLOW LOW PRO VALVE
K093968 · JXG
Integra LifeSciences Corporation
Neurology · 30d
Cleared Jan 21, 2010
DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM,...
K092388 · GXQ
Integra LifeSciences Corporation
Neurology · 169d
Cleared Jan 21, 2010
MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V,...
K093919 · HCG
MicroVention, Inc.
Neurology · 30d
Cleared Jan 15, 2010
COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG
K093223 · GWQ
Compumedics Limited
Neurology · 94d
Cleared Jan 15, 2010
MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V
K093358 · HCG
MicroVention, Inc.
Neurology · 79d
Cleared Jan 13, 2010
AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE
K093825 · IKT
Ambu A/S
Neurology · 30d