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
32209–32232 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 2016
Bi-Blade Vitrectomy Cutter
K153168 · HQE
Medical Instrument Development...
Ophthalmic · 179d
Cleared Apr 29, 2016
Alphatec Navigation Instruments
K153603 · OLO
Alphatec Spine, Inc.
Orthopedic · 134d
Cleared Apr 29, 2016
Crosstella OTW
K160004 · LIT
KANEKA Corporation
Cardiovascular · 116d
Cleared Apr 29, 2016
Crosperio OTW
K160013 · LIT
KANEKA Corporation
Cardiovascular · 116d
Cleared Apr 29, 2016
Besmed PEEP Valve
K160112 · BYE
Besmed Health Business Corp
Anesthesiology · 101d
Cleared Apr 29, 2016
OsteoBullet Compression Screw
K160304 · HWC
Phalanx Innovations
Orthopedic · 85d
Cleared Apr 29, 2016
MC-Subtalar(TM) II
K160548 · HWC
Merete Medical GmbH
Orthopedic · 60d
Cleared Apr 29, 2016
Denali Filter System - Femoral Delivery Kit, Denali Filter System -...
K160866 · DTK
C.R. Bard, Inc.
Cardiovascular · 30d
Cleared Apr 29, 2016
Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair...
K160869 · FTM
Cook Biotech Incorporated
General & Plastic Surgery · 30d
Cleared Apr 28, 2016
Blockade Surgical Gown
K150598 · FYA
Medline Industries, Inc.
General Hospital · 416d
Cleared Apr 28, 2016
ManoScan System
K151086 · FFX
Given Imaging , Ltd.
Gastroenterology & Urology · 372d
Cleared Apr 28, 2016
ARCHITECT ROMA
K151502 · ONX
Fujirebio Diagnostics,Inc.
Immunology · 329d
Cleared Apr 28, 2016
3Shape Ortho System
K152086 · PNN
3Shape A/S
Dental · 276d
Cleared Apr 28, 2016
BRILLIANT EVERGLOW
K152927 · EBF
Coltene/Whaledent AG
Dental · 206d
Cleared Apr 28, 2016
Endopath Electrosurgery Probe Plus II
K160128 · GEI
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 99d
Cleared Apr 27, 2016
Elecsys Cortisol II, Cortisol II CalSet
K152227 · JFT
Roche Diagnostics
Chemistry · 264d
Cleared Apr 27, 2016
EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES
K152724 · HQD
Advanced Vision Technologies
Ophthalmic · 218d
Cleared Apr 27, 2016
Syzygy Stabilization System
K153152 · NKB
Amendia, Inc.
Orthopedic · 177d
Cleared Apr 27, 2016
Pyrenees Cervical Plate System
K153526 · KWQ
K2m
Orthopedic · 140d
Cleared Apr 27, 2016
Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)
K160202 · LEH
Siemens Healthcare Diagnostics, Inc.
Toxicology · 90d
Cleared Apr 27, 2016
Wet Original Personal Lubricant
K160211 · NUC
Trigg Laboratories D/B/A Wet...
Obstetrics & Gynecology · 90d
Cleared Apr 27, 2016
Dual Pump Pack
K160236 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 86d
Cleared Apr 27, 2016
OmniPod Insulin Management System
K160252 · LZG
Insulet Corporation
General Hospital · 86d
Cleared Apr 26, 2016
ISEN-Goggles
K152727 · GWN
Isen Tech & Trading Company, Ltd.
Neurology · 217d