FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68569–68592 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 03, 2004
NDX-40 ALLOY
K040043 · EJT
Heraeus Kulzer, Inc.
Dental · 51d
Cleared Mar 03, 2004
CONTINUM
K040179 · EJH
Aalba Dent, Inc.
Dental · 36d
Cleared Mar 03, 2004
CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR
K040210 · DTZ
Terumo Corp.
Cardiovascular · 33d
Cleared Mar 03, 2004
PLUME SAFETY AVF NEEDLE
K040247 · FIE
Jms North America Corp.
Gastroenterology & Urology · 29d
Cleared Mar 03, 2004
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)
K040300 · ERL
Stryker Instruments
Ear, Nose, Throat · 23d
Cleared Mar 03, 2004
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A...
K040357 · MHX
Philips Medical Systems, Inc.
Cardiovascular · 19d
Cleared Mar 02, 2004
NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III...
K023342 · KOI
Hdc Corp.
Anesthesiology · 512d
Cleared Mar 02, 2004
CT OIA
K032330 · LJC
Thermo Biostar, Inc.
Microbiology · 217d
Cleared Mar 02, 2004
THE FRIENDLYLIGHT ND: YAG LASERS
K033251 · GEX
Innotech USA, Inc.
General & Plastic Surgery · 147d
Cleared Mar 02, 2004
KENKOWAVE INFRARED PAIN TREATMENT SYSTEM
K033555 · ILY
Kaylight Corporation
Physical Medicine · 111d
Cleared Mar 02, 2004
NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000
K033619 · HAW
Image-Guided Neurologics, Inc.
Neurology · 105d
Cleared Mar 02, 2004
CT-MASS
K033774 · JAK
Medis Medical Imaging Systems BV
Radiology · 90d
Cleared Mar 02, 2004
SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM
K033816 · JDQ
Synthes (Usa)
Orthopedic · 84d
Cleared Mar 02, 2004
DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K),...
K033851 · JIL
Hypoguard USA, Inc.
Chemistry · 82d
Cleared Mar 02, 2004
MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE
K033881 · DXT
Medrad, Inc.
Cardiovascular · 78d
Cleared Mar 02, 2004
NON-STERILE BLUE & WHITE COLOUR POWDER FREE BARRIER PRO POLYBUTADIENE...
K033887 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 78d
Cleared Mar 02, 2004
A1C-CELLULAR
K040025 · JJX
Streck Laboratories, Inc.
Chemistry · 55d
Cleared Mar 02, 2004
VIVARING MICROWAVE ABLATION PROBE
K040279 · GEI
Vivant Medical, Inc.
General & Plastic Surgery · 26d
Cleared Mar 02, 2004
MODIFICATION TO NITREX NITINOL GUIDEWIRE
K040345 · DQX
Ev3, Inc.
Cardiovascular · 19d
Cleared Mar 01, 2004
CANNULATED METALLIC HEMI TOE IMPLANT, MODELS MPJ241975, MPJ221775, MPJ211675,...
K023684 · KWD
Vilex, Inc.
Orthopedic · 486d
Cleared Mar 01, 2004
INION OTPS BIODEGRADABLE MESH PLATING SYSTEM
K031961 · HRS
Inion , Ltd.
Orthopedic · 250d
Cleared Mar 01, 2004
MODIFIED SONAMET BODY COMPOSITION ANALYZER
K032610 · OAC
Life Measurement, Inc.
Obstetrics & Gynecology · 189d
Cleared Mar 01, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFEPIME (GN) 0.5-65 UG/ML
K032675 · LON
Becton, Dickinson & CO
Microbiology · 185d
Cleared Mar 01, 2004
CLO-SURPLUSP.A.D.
K032986 · QSY
Scion Cardio-Vascular, Inc.
General & Plastic Surgery · 159d