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
21073–21096 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 01, 2019
XIHPOS™ ZFUZE™ Interbody Fusion System
K190544 · MAX
Difusion Technologies
Orthopedic · 242d
Cleared Nov 01, 2019
BD Acute Central Line
K190855 · FOZ
Bard Access Systems, Inc. (Bard Has...
General Hospital · 213d
Cleared Nov 01, 2019
Sight OLO
K190898 · GKZ
Sight Diagnostics , Ltd.
Hematology · 210d
Cleared Nov 01, 2019
COPAL exchange G Hip and Knee Spacers
K191016 · KWY
Heraeus Medical GmbH
Orthopedic · 198d
Cleared Nov 01, 2019
Perfect PFE
K191312 · KPI
Tenscare, Ltd.
Gastroenterology & Urology · 170d
Cleared Nov 01, 2019
NextDent Denture 3D+
K191497 · EBI
Vertex-Dental B.V.
Dental · 149d
Cleared Nov 01, 2019
Stealth Autoguide System, Midas Rex Legend Depth Stop System
K191597 · HAW
Medtronic Navigation, Inc.
Neurology · 137d
Cleared Nov 01, 2019
Delta Multihole TT Pro Acetabular System
K191622 · LPH
Lima Corporate S.P.A.
Orthopedic · 136d
Cleared Nov 01, 2019
ZMAXX Dental Zirconia Blanks
K191631 · EIH
Zmaxx Bioceramics, LLC
Dental · 135d
Cleared Nov 01, 2019
LEGION System
K191650 · HQC
Alcon Research, LLC
Ophthalmic · 134d
Cleared Nov 01, 2019
BC-5
K191693 · GEX
Reveallux, Corp
General & Plastic Surgery · 129d
Cleared Nov 01, 2019
Combo Electrotherapy Device
K192087 · NUH
Shenzhen Roundwhale Technology Co. ,...
Neurology · 88d
Cleared Nov 01, 2019
CAPI 3 Immunotyping, Capillarys 3 Tera
K192095 · CFF
Sebia
Immunology · 88d
Cleared Nov 01, 2019
Small VBR™
K192117 · MQP
Ulrich GmbH & Co. KG
Orthopedic · 87d
Cleared Nov 01, 2019
Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable...
K192278 · HIH
Uvision360, Inc.
Obstetrics & Gynecology · 71d
Cleared Nov 01, 2019
FDR SE Lite
K192440 · MQB
Fujifilm Corporation
Radiology · 56d
Cleared Oct 31, 2019
mediCAD Web
K183412 · LLZ
Medicad Hectec GmbH
Radiology · 325d
Cleared Oct 31, 2019
StimRouter Neuromodulation System
K190047 · GZF
Bioness, Inc.
Neurology · 295d
Cleared Oct 31, 2019
Ultrasonic Surgical System
K190281 · LFL
Medisonic Technology CO
General & Plastic Surgery · 262d
Cleared Oct 31, 2019
Claritag
K190747 · GEH
Dgi Technologies
General & Plastic Surgery · 223d
Cleared Oct 31, 2019
OR3O Dual Mobility System
K191002 · LPH
Smith & Nephew, Inc.
Orthopedic · 198d
Cleared Oct 31, 2019
ePM Series Patient monitors
K191769 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 122d
Cleared Oct 31, 2019
Belimed Steam Sterilizer MST-H TOP 5000
K191896 · FLE
Belimed AG
General Hospital · 108d
Cleared Oct 31, 2019
Vitek Densichek
K192110 · LON
bioMerieux, Inc.
Microbiology · 87d