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
29401–29424 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 03, 2017
AxSOS 3 Ti
K162439 · HRS
Stryker GmbH
Orthopedic · 156d
Cleared Feb 03, 2017
GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated...
K162536 · MVL
Kerr Corporation
Dental · 144d
Cleared Feb 03, 2017
RehaStim 2
K162683 · GZI
Hasomed GmbH
Neurology · 130d
Cleared Feb 03, 2017
MTM Clear Aligner
K163155 · NXC
Dentsply Sirona
Dental · 85d
Cleared Feb 03, 2017
PICC Maximal Barrier Nursing Kit
K163452 · LJS
Navilyst Medical, Inc.
General Hospital · 56d
Cleared Feb 03, 2017
LenSx Laser System
K163551 · OOE
Alcon Laboratories, Inc.
Ophthalmic · 46d
Cleared Feb 02, 2017
Titan 3W
K160835 · INI
Tzora Active Systems , Ltd.
Physical Medicine · 314d
Cleared Feb 02, 2017
US SA Implant System
K161103 · DZE
Osstem Implant Co., Ltd.
Dental · 289d
Cleared Feb 02, 2017
0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe
K161552 · NGT
Becton, Dickinson and Company
General Hospital · 241d
Cleared Feb 02, 2017
Q-Switched Nd:YAG Laser Therapy Systems
K163123 · GEX
Beijing Sincoheren Science and...
General & Plastic Surgery · 86d
Cleared Feb 02, 2017
FlexCath Select Steerable Shealth and Dilator
K163268 · DYB
Medtronic Cryocath, LP
Cardiovascular · 73d
Cleared Feb 02, 2017
HA Minuteman G3-R MIS Fusion Plate
K163428 · PEK
Spinal Simplicity
Orthopedic · 58d
Cleared Feb 02, 2017
NovaGuard SA Pro Safety System
K163511 · MEG
West Pharmaceutical Services, Inc.
General Hospital · 49d
Cleared Feb 02, 2017
Aquilion Lightning, TSX-036A/1, V8.4
K170019 · JAK
Toshibamedical Systems Corporation
Radiology · 30d
Cleared Feb 02, 2017
ProMIS™ Fixation System
K170061 · NKB
Premia Spine, Ltd.
Orthopedic · 27d
Cleared Feb 01, 2017
Life Spine Metatarsal Hemi Implant
K161279 · KWD
Life Spine, Inc.
Orthopedic · 271d
Cleared Feb 01, 2017
U2 Total Knee System, PSA Tibial Insert
K161360 · JWH
United Orthopedic Corporation
Orthopedic · 261d
Cleared Feb 01, 2017
Memodyn Staple
K161587 · JDR
Austin & Associates, Inc./Telos...
Orthopedic · 238d
Cleared Feb 01, 2017
iHealth Wireless Blood Pressure Monitor
K162144 · DXN
Andon Health Co, Ltd.
Cardiovascular · 184d
Cleared Feb 01, 2017
PicoWay Laser System
K162454 · GEX
Syneron Candela Corporation
General & Plastic Surgery · 153d
Cleared Feb 01, 2017
Twin-Pass Torque
K162467 · DQY
Vascular Solutions, Inc.
Cardiovascular · 152d
Cleared Feb 01, 2017
Pre-Formed Penile Silicone Block
K162624 · MIB
International Medical Devices, Inc.
General & Plastic Surgery · 134d
Cleared Feb 01, 2017
Exactech® Equinoxe® Preserve Stem
K162726 · PHX
Exactech, Inc.
Orthopedic · 125d
Cleared Feb 01, 2017
MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface
K162958 · DTR
Medtronic, Inc.
Cardiovascular · 100d