FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
19969–19992 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 18, 2020
WIRION
K200198 · NTE
Cardiovascular Systems, Inc.
Cardiovascular · 51d
Cleared Mar 18, 2020
Evolve Breast Pump
K200406 · HGX
Hygeia II Medical Group, Inc.
Obstetrics & Gynecology · 28d
Cleared Mar 18, 2020
VIVIX-S VW
K200418 · MQB
Vieworks Co., Ltd.
Radiology · 27d
Cleared Mar 17, 2020
Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For...
K191753 · LZA
Medline Industries, Inc.
General Hospital · 260d
Cleared Mar 17, 2020
TheraBase, TheraBase Ca
K192007 · EMA
Bisco, Inc.
Dental · 232d
Cleared Mar 17, 2020
Wolf445nm
K192272 · GEX
A.R.C Laser GmbH
General & Plastic Surgery · 208d
Cleared Mar 17, 2020
NeuralScan System
K192753 · GWQ
Medeia, Inc.
Neurology · 169d
Cleared Mar 17, 2020
myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)
K193310 · MXC
Abbott (St. Jude Medical)
Cardiovascular · 109d
Cleared Mar 17, 2020
SterilContainer S2 System
K193582 · KCT
Aesculap, Inc.
General Hospital · 85d
Cleared Mar 17, 2020
Shear Wave Quantificational Ultrasound Diagnostic System
K200136 · IYO
Wuxi Hisky Medical Technologies Co.,...
Radiology · 56d
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