FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

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175,820 results
20569–20592 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 17, 2020
Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral,...
K200151 · HSX
Zimmer, Inc.
Orthopedic · 55d
Cleared Mar 17, 2020
ACUVUE (senofilcon A) Soft Contact Lens Multifocal
K200243 · LPL
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 46d
Cleared Mar 17, 2020
iBalance UKA Tibial Tray Implant
K200433 · HSX
Arthrex, Inc.
Orthopedic · 25d
Cleared Mar 17, 2020
EndoTool IV 1.10
K200443 · NDC
Monarch Medical Technologies, LLC
Chemistry · 22d
Cleared Mar 16, 2020
Transferrin
K190495 · DDG
Biosystems S.A.
Immunology · 382d
Cleared Mar 16, 2020
AnatomicAligner
K190767 · LLZ
The Methodist Hospital Research...
Dental · 357d
Cleared Mar 16, 2020
OptikView GUP2103CMI
K191705 · PGY
The Linden Group Corp
Radiology · 264d
Cleared Mar 16, 2020
Sunmed Disposable Angio-Closure Pads
K191827 · DXC
Sunny Medical Device (Shenzhen) Co.,...
Cardiovascular · 252d
Cleared Mar 16, 2020
Altera Filter and HME/Filter
K192713 · CAH
Meditera Tibbi Malzeme San VE Tic AS
General Hospital · 171d
Cleared Mar 16, 2020
Al-Rad Companion (Musculoskeletal)
K193267 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 111d
Cleared Mar 16, 2020
Epic 980
K193486 · GEX
Biolase, Inc.
General & Plastic Surgery · 90d
Cleared Mar 16, 2020
Response BandLoc Spinal Fixation
K200097 · OWI
OrthoPediatrics Corp.
Orthopedic · 60d
Cleared Mar 16, 2020
SANDRO Dual
K200110 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 59d
Cleared Mar 16, 2020
CONTINUUM PACS
K200385 · NFJ
Integrated Ophthalmic Systems, Inc.
Ophthalmic · 27d
Cleared Mar 16, 2020
AERO CHROME* Breathable Performance Surgical Gowns
K200522 · FYA
O&M Halyard, Inc.
General Hospital · 14d
Cleared Mar 14, 2020
Health Expert Electronic Stimulator (model: AST-300L)
K190783 · NUH
Shenzhen Osto Technology Company Limited
Neurology · 353d
Cleared Mar 13, 2020
Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential...
K191869 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 245d
Cleared Mar 13, 2020
NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC...
K192162 · GXR
Neurovention, LLC
Neurology · 217d
Cleared Mar 13, 2020
Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free...
K192241 · LZA
O&M Haylard, Inc.
General Hospital · 207d
Cleared Mar 13, 2020
MeDioStar
K192483 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 185d
Cleared Mar 13, 2020
GIA Stapler with Tri-Staple Technology
K192720 · GDW
Covidien
General & Plastic Surgery · 168d
Cleared Mar 13, 2020
Curian HpSA, Curian Analyzer
K192817 · LYR
Meridian Bioscience, Inc.
Microbiology · 164d
Cleared Mar 13, 2020
EzOrtho
K192888 · LLZ
Ewoosoft Co., Ltd.
Radiology · 155d
Cleared Mar 13, 2020
32HL512D
K192925 · PGY
Lg Electronics.Inc
Radiology · 149d