Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
33985–34008 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 21, 2015
Telio CAD Abutment Solutions
K151564 · NHA
Ivoclar Vivadent, AG
Dental · 103d
Cleared Sep 21, 2015
Chameleon PTA Balloon Catheter
K151678 · LIT
Av Medical Technologies, Ltd.
Cardiovascular · 91d
Cleared Sep 21, 2015
CARESTREAM Vue Motion
K151774 · LLZ
Carestream Health, Inc.
Radiology · 82d
Cleared Sep 21, 2015
Hummingbird Tympanostomy Tube
K151830 · ETD
Preceptis Medical
Ear, Nose, Throat · 77d
Cleared Sep 21, 2015
AVERT Contrast Modulation System
K152218 · DXT
Osprey Medical
Cardiovascular · 45d
Cleared Sep 21, 2015
Ceramill Zolid FX
K152383 · EIH
Emergo Europe Consulting
Dental · 28d
Cleared Sep 21, 2015
Hi-Torque Command 18 Guide Wire
K152404 · DQX
Abbott Vascular
Cardiovascular · 27d
Cleared Sep 21, 2015
Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack
K152408 · OCC
Focus Diagnostics, Inc.
Microbiology · 27d
Cleared Sep 21, 2015
ACUSON NX3 Elite / NX3 Diagnostic Ultrasound System
K152469 · IYN
Siemens Medical Solutions, Inc.,...
Radiology · 21d
Cleared Sep 18, 2015
Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid...
K142293 · LAF
Biophor Diagnostics, Inc.
Toxicology · 396d
Cleared CT Sep 18, 2015
DeVilbiss Intellipap2/DeVilbiss BLUE
K143677 · BZD
Devilbiss Healthcare, LLC
Anesthesiology · 268d
Cleared Sep 18, 2015
Spirit
K143696 · EIA
Pelton & Crane
Dental · 268d
Cleared Sep 18, 2015
Dimension Vista MMB Assay
K143720 · JHY
Siemens Healthcare Diagnostics
Chemistry · 263d
Cleared Sep 18, 2015
ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH
K143743 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 261d
Cleared Sep 18, 2015
PROPEL device
K150392 · DZJ
Propel Orthodontics, LLC
Dental · 212d
Cleared Sep 18, 2015
AF541 SE Full Face Mask
K150638 · CBK
Respironics, Inc.
Anesthesiology · 191d
Cleared Sep 18, 2015
AF541 EE Full Face Mask
K150639 · BZD
Respironics, Inc.
Anesthesiology · 191d
Cleared Sep 18, 2015
Circumplast Circumcision Device
K151095 · HFX
Novadien Healthcare
Obstetrics & Gynecology · 148d
Cleared Sep 18, 2015
Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System
K151189 · JOW
Devon Medical Products
Cardiovascular · 137d
Cleared Sep 18, 2015
Clinpro Varnish
K151302 · LBH
3M Company
Dental · 126d
Cleared Sep 18, 2015
Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein...
K151392 · KGO
Terang Nusa Sdn Bhd
General Hospital · 115d
Cleared Sep 18, 2015
Recovr Rehabilitation System
K151446 · LXJ
Recovr,Inc
Physical Medicine · 112d
Cleared Sep 18, 2015
BRUSH&BOND PLUS
K151518 · KLE
Parkell, Inc.
Dental · 105d
Cleared Sep 18, 2015
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim(Blue)
K151684 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 88d