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
26401–26424 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 21, 2018
cobas CT/NG for use on cobas 6800/8800 systems
K173887 · LSL
Roche Molecular Systems, Inc.
Microbiology · 90d
Cleared CT Mar 21, 2018
WIRION
K180023 · NTE
Gardia Medical , Ltd.
Cardiovascular · 77d
Cleared Mar 21, 2018
ATS Thermal Imaging Probe, ATS Patient Interface Unit
K180148 · FLL
Securus Medical Group, Inc.
General Hospital · 61d
Cleared Mar 21, 2018
Emprint Ablation Visualization Application
K180192 · LLZ
Covidien, LLC
Radiology · 56d
Cleared Mar 21, 2018
Freezpoint
K180211 · GEH
Bovie Medical Corp.
General & Plastic Surgery · 55d
Cleared Mar 21, 2018
Ventix Link Knotless Anchor with Inserter
K180274 · MBI
Cayenne Medical, Inc.
Orthopedic · 49d
Cleared Mar 20, 2018
ReConnex Pre-Sutured Tendon
K170957 · GAT
Allosource
General & Plastic Surgery · 354d
Cleared Mar 20, 2018
Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon...
K171989 · ODD
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 260d
Cleared Mar 20, 2018
Single Use Hemoclip
K172762 · PKL
Zhejiang Chuangxiang Medical...
Gastroenterology & Urology · 188d
Cleared Mar 20, 2018
Ingenia Elition S and Ingenia Elition X
K173451 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 134d
Cleared Mar 20, 2018
HX Device
K173919 · GCJ
Human Extension , Ltd.
General & Plastic Surgery · 88d
Cleared Mar 20, 2018
Philips Incisive CT
K180015 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 77d
Cleared Mar 20, 2018
Home Use IPL Beauty Device
K180016 · OHT
Shenzhen Mismon Technology Co., Ltd.
General & Plastic Surgery · 77d
Cleared CT Mar 20, 2018
Habib EndoHPB
K180165 · KNS
Emcision , Ltd.
Gastroenterology & Urology · 57d
Cleared Mar 20, 2018
BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
K180438 · PSZ
Bd
Microbiology · 28d
Cleared Mar 19, 2018
Anjon Bremer Halo System
K171863 · JEC
Anjon Holdings, LLC
Orthopedic · 270d
Cleared Mar 19, 2018
Double Flexible Tip Wire Guides
K171912 · DQX
Cook Incorporated
Cardiovascular · 266d
Cleared Mar 19, 2018
Anchorage Bone Plating System
K172148 · HRS
Stryker GmbH
Orthopedic · 245d
Cleared Mar 19, 2018
OTW Takeru PTCA Balloon Dilatation Catheter
K172264 · LOX
KANEKA Corporation
Cardiovascular · 235d
Cleared Mar 19, 2018
Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry...
K173237 · LFD
Syendgen, Inc.
Dental · 165d
Cleared Mar 19, 2018
3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest...
K173437 · FRC
3M Company
General Hospital · 136d
Cleared Mar 19, 2018
Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads
K173499 · JDG
Stryker Orthopaedics
Orthopedic · 126d
Cleared Mar 19, 2018
Reprocessed DePuy Mitek Ablation Wand
K173740 · NUJ
Renovo, Inc.
General & Plastic Surgery · 102d
Cleared Mar 19, 2018
PYTHON Plate Trial Instruments
K173930 · HRS
Treace Medical Concepts, Inc.
Orthopedic · 83d