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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
28081–28104 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 03, 2017
NavLock Trackers
K171267 · OLO
Medtronic Navigation
Orthopedic · 63d
Cleared Jul 03, 2017
YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up
K171653 · DQY
Codman & Shurtleff, Inc.
Cardiovascular · 28d
Cleared Jul 01, 2017
ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip
K171613 · MOF
Asahi Intecc Co., Ltd.
Neurology · 30d
Cleared Jun 30, 2017
DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy...
K160553 · HRS
Synthes (Usa) Products, LLC / Depuy...
Orthopedic · 487d
Cleared Jun 30, 2017
NextDent Denture, E-Denture
K162572 · EBI
Vertex-Dental B.V.
Dental · 288d
Cleared Jun 30, 2017
iVitri EZ
K162640 · MQK
Reprobitech Corp.
Obstetrics & Gynecology · 281d
Cleared Jun 30, 2017
Gelweave Vascular Grafts
K162794 · DSY
Vascutek, Ltd.
Cardiovascular · 269d
Cleared Jun 30, 2017
Dynamic Visualization II Image Processing Option for the FDX Console...
K163624 · MQB
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 190d
Cleared Jun 30, 2017
Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1
K170177 · JAK
Toshibamedical Systems Corporation
Radiology · 162d
Cleared Jun 30, 2017
GRAVITY™ Syndesmosis LP
K170249 · HTN
Wrightmedicaltechnologyinc
Orthopedic · 154d
Cleared Jun 30, 2017
SpiralTech Dental Implant System
K170372 · DZE
Spiraltech Superior Dental Implants,...
Dental · 143d
Cleared Jun 30, 2017
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs...
K170794 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 106d
Cleared Jun 30, 2017
FIBERGRAFT BG Matrix Bone Graft Substitute
K171284 · MQV
Prosidyan, Inc.
Orthopedic · 60d
Cleared Jun 30, 2017
Smart External Drain (SED) System
K171586 · JXG
Aqueduct Critical Care, Inc.
Neurology · 30d
Cleared Jun 30, 2017
ACUITY Pro Lead Delivery System
K171612 · DQY
Boston Scientific Corporation
Cardiovascular · 29d
Cleared Jun 30, 2017
Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall...
K171621 · MHX
Welch Allyn, Inc.
Cardiovascular · 28d
Cleared Jun 30, 2017
Infinity-Lock 3, Infinity-Lock 5
K171680 · GAT
Xiros, Ltd.
General & Plastic Surgery · 24d
Cleared Jun 29, 2017
SAGICO IBF SYSTEM – ARIA LUMBAR, SAGICO IBF SYSTEM – ARION CERVICAL
K161710 · MAX
Spinal Analytics & Geometrical Impant...
Orthopedic · 373d
Cleared Jun 29, 2017
ADAMS A1c HA-8180V, CALIBRATOR 80
K162822 · PDJ
Arkray Factory, Inc.
Chemistry · 265d
Cleared Jun 29, 2017
PHA S1 Spinal System
K163011 · NKB
Phamedica, Inc.
Orthopedic · 244d
Cleared Jun 29, 2017
Parietene DS Composite Mesh
K163212 · FTL
Sofradim Production
General & Plastic Surgery · 225d
Cleared Jun 29, 2017
SMR Hybrid Glenoid System
K163397 · MBF
Lima Corporate S.P.A.
Orthopedic · 206d
Cleared Jun 29, 2017
Vessel Dilator
K163524 · DWP
Fetzer Medical GmbH & Co. KG
Cardiovascular · 196d
Cleared Jun 29, 2017
Firebow Wire Torque Assist Device
K170684 · DQX
Vesatek, LLC
Cardiovascular · 114d