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
15457–15480 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 01, 2021
Medical Endoscope Image Processing System
K210270 · HIH
Jiangsu Jiyuan Medical Technology...
Obstetrics & Gynecology · 242d
Cleared Oct 01, 2021
HRSpheres Narrow-Size Embolic Microspheres
K210562 · KRD
Suzhou Hengrui Hongyuan Medical Co.,...
Obstetrics & Gynecology · 218d
Cleared Oct 01, 2021
Porous Patella and Porous Tibia Baseplate
K211221 · MBH
Smith & Nephew, Inc.
Orthopedic · 161d
Cleared Oct 01, 2021
D Camera Controller
K211332 · FET
Richard Wolf Medical Instruments...
Gastroenterology & Urology · 151d
Cleared Oct 01, 2021
Elekta Unity
K212114 · IYE
Elekta Solutions AB
Radiology · 86d
Cleared Oct 01, 2021
PENTAX Medical Auto Leakage Tester SHA-P6
K212201 · PCV
Pentax of America, Inc.
Gastroenterology & Urology · 79d
Cleared Oct 01, 2021
OSSDSIGN Cranial PSI
K212414 · PJN
Ossdsign AB
Neurology · 59d
Cleared Oct 01, 2021
Anthem Fracture System
K212433 · HRS
Globus Medical, Inc.
Orthopedic · 58d
Cleared Oct 01, 2021
Zenition 70
K212813 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 28d
Cleared Oct 01, 2021
BRIUS Planner Software
K212828 · PNN
Brius Technologies, Inc.
Dental · 28d
Cleared Sep 30, 2021
Acuitas AMR Gene Panel
K191288 · PMY
Opgen, Inc.
Microbiology · 871d
Cleared Sep 30, 2021
Intravascular Administration Sets
K203609 · FPA
Baxter Healthcare Corporation
General Hospital · 294d
Cleared Sep 30, 2021
Implanova
K210523 · DZE
Dental Evolutions, Inc.
Dental · 219d
Cleared Sep 30, 2021
Small Bone Nailing System
K211439 · HTY
Skeletal Dynamics, Inc.
Orthopedic · 143d
Cleared Sep 30, 2021
Playboy 3 Contour Condom
K211450 · HIS
Thai Nippon Rubber Industry Public...
Obstetrics & Gynecology · 143d
Cleared Sep 30, 2021
NAEOTOM Alpha, Scan&GO
K211591 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 129d
Cleared Sep 30, 2021
Enteral Pump Syringe
K211593 · PNR
Jiangsu Caina Medical Co.,Ltd
Gastroenterology & Urology · 129d
Cleared Sep 30, 2021
ORIO-Ti Intervertebral Body Fusion Cage System
K211935 · ODP
Spinecraft, LLC
Orthopedic · 100d
Cleared Sep 30, 2021
Philips IntelliVue GuardianSoftware (Rev. E.0X)
K212208 · DXJ
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 77d
Cleared Sep 30, 2021
Philips MR Patient Care Portal
K212227 · MWI
Invivo Corporation
Cardiovascular · 76d
Cleared Sep 30, 2021
AngioVac F18 85
K212386 · DWF
AngioDynamics, Inc.
Cardiovascular · 59d
Cleared Sep 30, 2021
EMERGE™ Anterior Cervical Plate System
K212405 · KWQ
Evolution Spine
Orthopedic · 59d
Cleared Sep 30, 2021
Jada System
K212757 · OQY
Alydia Health
Obstetrics & Gynecology · 30d
Cleared Sep 30, 2021
Accuray Precision Treatment Planning System
K212794 · IYE
Accuray Incorporated
Radiology · 28d