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
36745–36768 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 20, 2014
TENURE4G
K140537 · KLE
Den-Mat Holdings, LLC
Dental · 169d
Cleared Aug 20, 2014
ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD
K140748 · DJG
Co-Innovation Biotech Co., Ltd.
Toxicology · 148d
Cleared Aug 20, 2014
STRAUMANN BONE LEVEL TAPERED IMPLANT
K140878 · DZE
Straumann USA, LLC
Dental · 135d
Cleared Aug 20, 2014
MULTIPIEZO PRO, MULTIPIEZO
K140965 · ELC
Mectron S.P.A.
Dental · 127d
Cleared Aug 20, 2014
NUTRA LIGHT RED
K141308 · OHS
Nutra Luxe MD, LLC
General & Plastic Surgery · 93d
Cleared Aug 20, 2014
OBSIDIAN MILLING BLOCKS
K141788 · EIH
Prismatik Dentalcraft, Inc.
Dental · 49d
Cleared Aug 19, 2014
SONOSENTRY
K131285 · PHZ
Isonea, Ltd.
Anesthesiology · 470d
Cleared Aug 19, 2014
VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE
K133952 · NGZ
bioMerieux, Inc.
Microbiology · 239d
Cleared Aug 19, 2014
OPA 30 SOLUTION
K140703 · MED
Ciden Technologies, LLC
General Hospital · 152d
Cleared Aug 19, 2014
NOMAD MD 75K V HANDHELD X-RAY SYSTEM
K140723 · IZL
Aribex, Inc.
Radiology · 151d
Cleared Aug 19, 2014
LEICA FL800
K141136 · IZI
Leica Biosystems Richmond
Radiology · 110d
Cleared Aug 19, 2014
IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL
K141772 · JJX
Siemens Healthcare Diagnostics, Inc.
Microbiology · 49d
Cleared Aug 19, 2014
ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES
K141979 · OWB
Philips Medical Systems Netherland BV
Radiology · 29d
Cleared Aug 19, 2014
M.U.S.T PEDICLE SCREW SYSTEM
K141988 · NKB
Medacta International
Orthopedic · 28d
Cleared Aug 18, 2014
PHYSIOGLOVE ET SYSTEM
K133703 · DXH
Commwell R&D , Ltd.
Cardiovascular · 258d
Cleared Aug 18, 2014
3M STERI-DRAPE FABRIC SURGICAL DRAPES
K140330 · KKX
3M Healthcare
General Hospital · 189d
Cleared Aug 18, 2014
CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM
K140585 · OJP
Curexo Technology Corporation
Orthopedic · 164d
Cleared Aug 18, 2014
M.U.S.T. EXTENSION
K141044 · NKB
Medacta International
Orthopedic · 117d
Cleared Aug 18, 2014
ENDOCYN ROOT CANAL IRRIGATION SOLUTION
K141352 · KJJ
Oculus Innovative Sciences
Dental · 87d
Cleared Aug 18, 2014
BIOLOX DELTA CERAMIC OPTION HEADS
K141653 · LZO
Biomet, Inc.
Orthopedic · 59d
Cleared Aug 18, 2014
OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER
K141769 · DQO
Lightlab Imaging, Inc.
Cardiovascular · 48d
Cleared Aug 18, 2014
SOLUTION SET/EXTENSION SET
K142011 · FPA
Baxter Healthcare Corporation
General Hospital · 25d
Cleared Aug 17, 2014
NUBRILLIANCE PULSED LIGHT HAIR REMOVAL DEVICE
K132518 · OHT
Wellquest Intl., Inc.
General & Plastic Surgery · 370d
Cleared Aug 15, 2014
THUNDERBOLT AND LANCER PEDICLE SCREW SYSTEMS
K132049 · NKB
Choicespine
Orthopedic · 409d