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
34033–34056 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 2015
SupaScoota Motorized vehicle
K143557 · INI
Eurogreen International, Inc.
Physical Medicine · 275d
Cleared Sep 16, 2015
OTSC Proctology
K150067 · PKL
Ovesco Endoscopy AG
Gastroenterology & Urology · 246d
Cleared Sep 16, 2015
Radio Therapy Treatment Chair
K150382 · IYE
Radiation Products Design, Inc.
Radiology · 210d
Cleared Sep 16, 2015
Biodesign Otologic Repair Graft
K150594 · KHJ
Cook Biotech Incorprated
Ear, Nose, Throat · 191d
Cleared Sep 16, 2015
XP3000
K150720 · PBX
BTL Industries, Inc.
General & Plastic Surgery · 181d
Cleared Sep 16, 2015
Straumann CARES Titanium Alloy (TAN) Abutment
K150899 · NHA
Straumann USA, LLC
Dental · 166d
Cleared Sep 16, 2015
Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products
K151400 · LEJ
Jk Holding GmbH
General & Plastic Surgery · 113d
Cleared Sep 16, 2015
syngo VSim
K151887 · MUJ
Siemens Medical Solutions USA, Inc.
Radiology · 68d
Cleared Sep 16, 2015
Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21)
K152030 · PGY
Qingdao Hisense Medical Equipment...
Radiology · 56d
Cleared Sep 16, 2015
ELUMI 810 + 980 Soft Tissue Laser
K152032 · GEX
Azena Medical, LLC
General & Plastic Surgery · 56d
Cleared Sep 16, 2015
Ultrasound Scanner System bk2300
K152052 · IYN
Bk Medical Aps
Radiology · 55d
Cleared Sep 16, 2015
RECON system - MPJ-Plates
K152142 · HRS
Normed Medizin-Technik GmbH
Orthopedic · 44d
Cleared Sep 16, 2015
MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)
K152346 · JWY
Beckman Coulter, Inc.
Microbiology · 27d
Cleared Sep 15, 2015
VITALA PORCINE DERIVED COLLAGEN MEMBRANE
K141177 · NPL
Osteogenics Biomedical, Inc....
Dental · 496d
Cleared Sep 15, 2015
Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series
K150111 · BZD
Apex Medical Corp.
Anesthesiology · 238d
Cleared Sep 15, 2015
Rhythm View Workstation (non-streaming, steaming option)
K151245 · DQK
Topera, Inc.
Cardiovascular · 127d
Cleared Sep 15, 2015
Occlusion Perfusion Catheter
K151554 · QEY
Advanced Catheter Therapies, Inc.
Cardiovascular · 98d
Cleared Sep 15, 2015
G.o.c.c.l.e.s.
K151630 · NXV
Pierrel Pharma S.R.L.
Dental · 90d
Cleared Sep 15, 2015
CO2RE System
K151655 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 89d
Cleared Sep 14, 2015
XEROSTOM SALIVA SUBSTITUTE GEL
K142657 · LFD
Bio Cosmetics, S.L.
Dental · 361d
Cleared Sep 14, 2015
KleenGel Dispenser
K143177 · KYX
Kleengel, LLC
General Hospital · 314d
Cleared Sep 14, 2015
Premium Surgiclip¿
K143644 · FZP
Covidien
General & Plastic Surgery · 266d
Cleared Sep 14, 2015
SuPro 100
K151144 · EBG
3M Deutschland GmbH
Dental · 138d
Cleared Sep 14, 2015
Powder Free Nitrile Examination Glove
K151208 · LZA
Vrg Khai Hoan Joint Stock Company
General Hospital · 131d