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

Filters: Cleared only ×
175,820 results
21577–21600 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 12, 2019
PENTAX Medical Video Upper GI Scopes (EG Family)
K190799 · FDS
Pentax of America, Inc.
Gastroenterology & Urology · 229d
Cleared Nov 12, 2019
xTAG Gastrointestinal Pathogen Panel (GPP)
K191161 · PCH
Luminex Molecular Diagnostics, Inc.
Microbiology · 195d
Cleared Nov 12, 2019
ARIX Wrist System
K191972 · HRS
Jeil Medical Corporation
Orthopedic · 111d
Cleared Nov 12, 2019
Clear21
K192202 · NJM
World Class Technology Corporation
Dental · 90d
Cleared Nov 12, 2019
AC3 Series Intra-Aortic Balloon Pump (IABP)
K192238 · DSP
Arrow International, Teleflex
Cardiovascular · 85d
Cleared Nov 12, 2019
LaseMD LEO Laser System
K192331 · GEX
Lutronic Global
General & Plastic Surgery · 77d
Cleared Nov 12, 2019
FDR D-EVO III flat panel detector system
K192932 · MQB
Fujifilm Corporation
Radiology · 26d
Cleared Nov 12, 2019
IDENTIFY
K192968 · IYE
Varian Medical Systems, Inc.
Radiology · 20d
Cleared Nov 10, 2019
DESS Dental Smart Solutions
K191986 · NHA
Terrats Medical SL
Dental · 108d
Cleared Nov 10, 2019
LATERA Absorbable Nasal Implant System
K192661 · NHB
Entellus Medical, Inc. (Aka Stryker Ent)
Ear, Nose, Throat · 46d
Cleared Nov 09, 2019
Omics Core
K190661 · PZM
Nanthealth, Inc.
Pathology · 240d
Cleared Nov 09, 2019
Neodent Implant System
K190958 · DZE
Jjgc Industria E Comercio DE...
Dental · 211d
Cleared Nov 08, 2019
PFC SIGMA Knee System
K182301 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 441d
Cleared Nov 08, 2019
BA Pit & Fissure Sealant
K190998 · EBC
Apex Dental Materials, Inc.
Dental · 206d
Cleared Nov 08, 2019
Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG*...
K191230 · LZC
O&M Halyard, Inc.
General Hospital · 184d
Cleared Nov 08, 2019
CERENOVUS Large Bore Catheter
K191237 · DQY
Codman & Shurtleff, Inc.
Neurology · 184d
Cleared Nov 08, 2019
PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family
K191282 · PEA
Pentax of America, Inc.
Gastroenterology & Urology · 179d
Cleared Nov 08, 2019
CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood...
K191286 · NBW
Ascensia Diabetes Care
Chemistry · 179d
Cleared Nov 08, 2019
Visalys CemCore, Visalys Cem Core Try In Paste
K191527 · EMA
Kettenbach GmbH & Co. KG
Dental · 151d
Cleared Nov 08, 2019
QuantX Breast MRI Biopsy Guidance Plugin
K191959 · LLZ
Qlarity Imaging
Radiology · 108d
Cleared Nov 08, 2019
Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1
K192019 · DQO
Abbott Medical
Cardiovascular · 102d
Cleared Nov 08, 2019
Oryx Cervical Plate System
K192049 · KWQ
Innovasis, Inc.
Orthopedic · 100d
Cleared Nov 08, 2019
CRP Vario
K192118 · DCK
SENTINEL CH. SpA
Immunology · 94d
Cleared Nov 08, 2019
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim...
K192232 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 84d