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

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175,820 results
31153–31176 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 2016
Matrix LS-40 CO2 Laser System
K161356 · GEX
Shanghai Wonderful Opto-Electrics...
General & Plastic Surgery · 116d
Cleared CT Sep 09, 2016
VPAP Adapt SV, VPAP Tx, S9 VPAP Tx
K161487 · MNS
Resmed, Ltd.
Anesthesiology · 101d
Cleared Sep 09, 2016
Arthrex Synergy RF System
K161581 · GEI
Arthrex, Inc.
General & Plastic Surgery · 93d
Cleared Sep 09, 2016
Tritium® Sternal Cable Plate System
K161876 · JDQ
Pioneer Surgical Technology, Inc....
Orthopedic · 63d
Cleared Sep 09, 2016
Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe...
K161915 · HIS
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 59d
Cleared Sep 09, 2016
TorqVue Low Profile Delivery Catheter
K162228 · DQY
Aga Medical Corporation (Wholly Owned...
Cardiovascular · 32d
Cleared Sep 08, 2016
BBX1, BBX2, BBX1MO, BBX1MC
K142846 · DZE
Globaldental, Inc.
Dental · 709d
Cleared Sep 08, 2016
coflex-IF
K153302 · PEK
Paradigm Spine, LLC
Orthopedic · 300d
Cleared Sep 08, 2016
Luna CPAP and Auto CPAP System
K153387 · BZD
3B Medical, Inc.
Anesthesiology · 290d
Cleared Sep 08, 2016
RTS Flexible 1 MPJ Implant w/Grommets
K153609 · KWH
In2bones USA, LLC
Orthopedic · 266d
Cleared Sep 08, 2016
Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable...
K160493 · NPK
Salvin Dental Specialties
Dental · 199d
Cleared Sep 08, 2016
Battalion Universal Spacer System
K160958 · PHM
Alphatec Spine
Orthopedic · 156d
Cleared Sep 08, 2016
PILLAR SA PTC
K161129 · OVD
Orthofix, Inc.
Orthopedic · 140d
Cleared Sep 08, 2016
StageOne Select Cement Spacer Molds for Temporary Hip Replacement
K161166 · MBB
Biomet, Inc.
Orthopedic · 135d
Cleared Sep 08, 2016
Navident
K161406 · PLV
Claronav, Inc.
Dental · 111d
Cleared Sep 08, 2016
SeaSpine® NewPort™ Spinal System
K161535 · NKB
SeaSpine Orthopedics Corporation
Orthopedic · 97d
Cleared Sep 08, 2016
BioFlo Midline Catheter
K161866 · FOZ
Navilyst Medical, Inc.
General Hospital · 63d
Cleared Sep 08, 2016
2MP Color LCD Monitor CCL214 (CL21214)
K161895 · PGY
Jvckenwood Corporation
Radiology · 59d
Cleared Sep 08, 2016
PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector
K161966 · MQB
Perkinelmer, Inc.
Radiology · 52d
Cleared Sep 08, 2016
SonoSite iViz Ultrasound System
K162288 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 24d
Cleared Sep 08, 2016
Symbia 6.5
K162337 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 17d
Cleared Sep 07, 2016
Additive Orthopaedics Bone Wedge System
K153207 · HRS
Additive Orthopaedics, LLC
Orthopedic · 307d
Cleared Sep 07, 2016
Pelican Sling Retractor
K153542 · GCJ
Beacon Surgical, Inc.
General & Plastic Surgery · 271d
Cleared Sep 07, 2016
Central Monitoring System
K153580 · HGM
Guangdong Biolight Meditech Co., Ltd.
Obstetrics & Gynecology · 267d