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
28345–28368 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 09, 2017
CKS Plus Knee System
K163167 · JWH
Consensus Orthopedics, Inc.
Orthopedic · 268d
Cleared Aug 09, 2017
M22 and ResurFx Systems
K170060 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 215d
Cleared Aug 09, 2017
Reperen Surgical Mesh
K170134 · FTL
Iconlab, Inc.
General & Plastic Surgery · 204d
Cleared Aug 09, 2017
Powered Wheelchair DYW30A(D09)
K170787 · ITI
Nanjing Jin Bai HE Medical Apparatus...
Physical Medicine · 146d
Cleared Aug 09, 2017
INTRACEPT Intraosseous Nerve Ablation System
K170827 · GXI
Relievant Medsystems
Neurology · 142d
Cleared Aug 09, 2017
WS80A Diagnostic Ultrasound System
K171070 · IYN
Samsung Medison Co., Ltd.
Radiology · 121d
Cleared Aug 09, 2017
StimSox(TM) System
K171071 · IPF
Stimmed, LLC
Physical Medicine · 121d
Cleared Aug 09, 2017
Epic Biliary Endoscopic Stent System
K171809 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 51d
Cleared Aug 09, 2017
DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES...
K172066 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 33d
Cleared Aug 09, 2017
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B...
K172091 · OZE
Centers For Disease Control and...
Microbiology · 29d
Cleared Aug 09, 2017
Fraxis
K172096 · GEX
Ilooda Co,., Ltd.
General & Plastic Surgery · 29d
Cleared Aug 08, 2017
Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated...
K162948 · MVL
Kerr Corporation
Dental · 291d
Cleared Aug 08, 2017
ImmuLisa Enhanced AMA IgG Antibody ELISA
K163133 · DBM
Immco Diagnostics, Inc.
Immunology · 273d
Cleared Aug 08, 2017
AFIAS iFOB with AFIAS-50
K163225 · OOX
Immunostics Inc.,
Hematology · 264d
Cleared Aug 08, 2017
iC-GPC Assay TM for use on the iC-SystemTM
K163390 · PAM
Icubate, Inc.
Microbiology · 249d
Cleared Aug 08, 2017
AxoGen Nerve Cap
K163446 · JXI
Axogen Corporation
Neurology · 243d
Cleared Aug 08, 2017
TruMatch CMF Titanium 3D Printed Implant System
K170272 · JEY
Materialise NV
Dental · 190d
Cleared Aug 08, 2017
Delight, Delight ortho, B&Lite S
K170529 · EBZ
Dentall Co., Ltd.
Dental · 167d
Cleared Aug 08, 2017
DESS Dental Smart Solutions
K170588 · NHA
Terrats Medical SL
Dental · 161d
Cleared Aug 08, 2017
MiniMAX
K170845 · LZO
Medacta International S.A.
Orthopedic · 140d
Cleared Aug 08, 2017
Renovis S141 Lumbar Interbody Fusion System
K170888 · MAX
Renovis Surgical Technologies
Orthopedic · 134d
Cleared Aug 08, 2017
Supplemental Instrument Trays
K170939 · KCT
Nuvasive Specialized Orthopedics,...
General Hospital · 131d
Cleared Aug 08, 2017
EVOLUTION Revision CCK System
K171389 · JWH
Microport Orthopedics, Inc.
Orthopedic · 89d
Cleared Aug 08, 2017
YUKON OCT Spinal System
K171444 · NKG
K2m, Inc.
Orthopedic · 84d