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
34105–34128 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 04, 2015
JuggerKnot Soft Anchors
K150768 · MBI
Biomet Manufacturing Corp
Orthopedic · 164d
Cleared Sep 04, 2015
Art-line Single channel blood pressure system, Art-line Double channel blood...
K151040 · DRS
Biometrix , Ltd.
Cardiovascular · 137d
Cleared Sep 04, 2015
Arcus Staple System
K151160 · JDR
Nextremity Solutions, Inc.
Orthopedic · 126d
Cleared Sep 04, 2015
PIEZOSURGERY WHITE
K151248 · DZI
Mectron S.P.A.
Dental · 116d
Cleared Sep 04, 2015
PUREWAY SHARPS COLLECTOR 1.2 GALLON, PUREWAY SHARPS COLLECTOR 2 GALLON,...
K151249 · MMK
Pureway Compliance, Inc.
General Hospital · 115d
Cleared Sep 04, 2015
CrossTIE Intraosseous Fixation System
K151270 · HWC
Crossroads Extremity Systems, LLC
Orthopedic · 114d
Cleared Sep 04, 2015
TOTAL COMPRESSION PLATING (TCP) SYSTEM
K151442 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 98d
Cleared Sep 04, 2015
Phoenix Thera-Lase System
K151521 · ILY
Phoenix Thera-Lase Systems, LLC
Physical Medicine · 91d
Cleared Sep 04, 2015
NuVasive PEEK Corpectomy Railed System
K151538 · MQP
Nu Vasive, Incorporated
Orthopedic · 88d
Cleared Sep 04, 2015
Xenco Medical Pedicle Screw System
K151733 · NKB
Xenco Medical, LLC
Orthopedic · 70d
Cleared Sep 04, 2015
ab medica irrigation/suction gravity system
K151822 · GCJ
Ab Medica Sas
General & Plastic Surgery · 60d
Cleared Sep 04, 2015
PRO-TOE Hammertoe Fixation System
K151838 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 60d
Cleared Sep 04, 2015
Pyrenees Cervical Plate System
K152015 · KWQ
K2m, Inc.
Orthopedic · 45d
Cleared Sep 04, 2015
Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
K152176 · LCM
Immunalysis Corporation
Toxicology · 31d
Cleared Sep 03, 2015
Peristeen Anal Irrigation System
K140310 · KNT
Coloplast A/S
Gastroenterology & Urology · 573d
Cleared Sep 03, 2015
Exactech® Novation® Crown Cup®
K141960 · LPH
Exactech, Inc.
Orthopedic · 412d
Cleared Sep 03, 2015
OPUS 5100 Diagnostic Doppler Ultrasound System
K142982 · IYN
Chang Gung Medical Technology Co., Ltd.
Radiology · 323d
Cleared Sep 03, 2015
Benefix Interspinous Fixation System
K143631 · PEK
U&I Corporation
Orthopedic · 255d
Cleared Sep 03, 2015
Model 206 Electrometer/Dosimeter
K150265 · IYE
Cnmc Company Incorporated
Radiology · 211d
Cleared Sep 03, 2015
Genesys Spine Apache Cervical Interbody Fusion System
K150812 · ODP
Genesys Spine
Orthopedic · 161d
Cleared Sep 03, 2015
SIC 8000
K150852 · PLL
Cosmo Technologies, Ltd.
Gastroenterology & Urology · 156d
Cleared Sep 03, 2015
NuVasive PEEK Corpectomy System
K151167 · MQP
Nu Vasive, Incorporated
Orthopedic · 125d
Cleared Sep 03, 2015
Klassic HD Hip System
K151440 · LPH
Total Joint Orthopedics, Inc.
Orthopedic · 97d
Cleared Sep 03, 2015
Leksell GammaPlan
K151666 · MUJ
Elekta Instrument AB
Radiology · 76d