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
35881–35904 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 02, 2014
STOPLOSS JONES TUBE
K140290 · OKS
Ljt Surgical, Ltd.
Ophthalmic · 300d
Cleared Dec 02, 2014
CLEARLUMEN THROMBECTOMY SYSTEM
K140296 · QEZ
Walk Vascular, LLC
Cardiovascular · 299d
Cleared Dec 02, 2014
MEDUSA VASCULAR PLUG,
K140796 · KRD
Endoshape, Inc.
Cardiovascular · 246d
Cleared Dec 02, 2014
PGS 5.5 MM CANNULATED PEDICLE SCREW
K141282 · NKB
Pinnacle Spine Group
Orthopedic · 200d
Cleared Dec 02, 2014
HEALTH2SYNC MOBILE APPLICATION, HEALTH2SYNC SMART CABLE
K141862 · NBW
H2, Inc.
Chemistry · 145d
Cleared Dec 02, 2014
GMK EXTENSION
K142069 · JWH
Medacta International
Orthopedic · 125d
Cleared Dec 02, 2014
Stryker Infrared Fluorescence (IRF) Imaging System
K142310 · OWN
Stryker Endoscopy
General & Plastic Surgery · 105d
Cleared Dec 02, 2014
Infrared Therapy System
K142340 · ILY
Beijing Huatai Healthcare Technology...
Physical Medicine · 103d
Cleared Dec 02, 2014
Skintact, various other tradenames
K142803 · MKJ
Leonhard Lang GmbH
Cardiovascular · 64d
Cleared Dec 02, 2014
ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set
K143164 · BSO
Kimberly Clark Corporation
Anesthesiology · 29d
Cleared Dec 01, 2014
SIVR56-T KIT
K133994 · DXJ
Barco N.V.
Cardiovascular · 340d
Cleared Dec 01, 2014
JULIET LL
K141135 · MAX
Spineart
Orthopedic · 214d
Cleared Dec 01, 2014
AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V,...
K142285 · FIP
Ameriwater
Gastroenterology & Urology · 105d
Cleared Dec 01, 2014
Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist...
K142471 · MVV
Pressure Point, Inc.
Neurology · 89d
Cleared Dec 01, 2014
Synapse 3D Liver and Kidney Analysis
K142521 · LLZ
Fujifilm Meidcal Systems U.S.A.,Inc.
Radiology · 84d
Cleared Dec 01, 2014
HairMax LaserComb, HairMax LaserComb
K142573 · OAP
Lexington International, LLC
General & Plastic Surgery · 80d
Cleared Dec 01, 2014
Chemtrue Multi-Panel DOA DIP Card Tests
K142580 · DKZ
Chemtron Biotech, Inc.
Toxicology · 77d
Cleared Dec 01, 2014
CD HORIZON Spinal System
K142591 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 77d
Cleared Dec 01, 2014
BP652N (HEM-6300-Z)
K142917 · DXN
Omron Healthcare, Inc.
Cardiovascular · 55d
Cleared Dec 01, 2014
Resolution Clip
K142973 · PKL
Boston Scientific Corporation
Gastroenterology & Urology · 48d
Cleared Dec 01, 2014
CD HORIZON Spinal System
K143141 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Nov 28, 2014
ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM
K140041 · OWB
Genoray Co., Ltd.
Radiology · 324d
Cleared Nov 28, 2014
nva, nvp, nvt
K142594 · MAX
Nvision Biomedical Technologies, LLC
Orthopedic · 74d
Cleared Nov 28, 2014
Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions,...
K143066 · HRS
Zimmer, Inc.
Orthopedic · 35d