FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
9193–9216 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 22, 2023
Nova HD+
K220938 · NGX
Aura Wellness, LLC
Physical Medicine · 509d
Cleared Aug 21, 2023
SM-IV
K232185 · IZL
Sedecal., Sa.
Radiology · 28d
Cleared Aug 21, 2023
Grappler Suture Anchor System
K231867 · MBI
Paragon 28, Inc.
Orthopedic · 56d
Cleared Aug 21, 2023
Stable-C Interbody System
K231763 · OVE
Nexus Spine, LLC
Orthopedic · 66d
Cleared Aug 21, 2023
Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software -...
K231731 · KPS
Mcgovern Medical School
Radiology · 69d
Cleared Aug 21, 2023
Pediatric Nailing Platform Tibia
K231266 · HSB
OrthoPediatrics Corp.
Orthopedic · 111d
Cleared Aug 21, 2023
Cove Strip
K230486 · MQV
SeaSpine Orthopedics Corporation
Orthopedic · 179d
Cleared Aug 21, 2023
Aveta System 2.0
K223813 · HIH
Meditrina, Inc.
Obstetrics & Gynecology · 244d
Cleared Aug 21, 2023
Plato 17 Microcatheter
K223560 · QJP
Scientia Vascular, Inc.
Neurology · 266d
Cleared Aug 21, 2023
ACR Screw System
K222245 · OAT
Biomaterials Korea, Inc.
Dental · 391d
Cleared Aug 19, 2023
LUX-Dx II (M302)
K231328 · MXD
Boston Scientific Corp
Cardiovascular · 103d
Cleared Aug 18, 2023
UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro -...
K232498 · EBC
Ultradent Product, Inc.
Dental · 1d
Cleared Aug 18, 2023
Connected OR Hub with Device and Voice Control, SDC4K Information Management...
K232157 · GCJ
Stryker Corporation
General & Plastic Surgery · 29d
Cleared Aug 18, 2023
Avéli
K232153 · OUP
Revelle Aesthetics, Inc.
General & Plastic Surgery · 30d
Cleared Aug 18, 2023
ZSFab Cervical Interbody System
K232150 · ODP
Zsfab, Inc.
Orthopedic · 30d
Cleared Aug 18, 2023
Sterile Products of the APTUS System
K232144 · HRS
Medartis AG
Orthopedic · 30d
Cleared Aug 18, 2023
Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W),...
K231777 · GEI
Olympus Winter & Ibe GmbH
General & Plastic Surgery · 63d
Cleared Aug 18, 2023
Holmium Medical Laser
K231718 · GEX
Allengers Global Healthcare Private...
General & Plastic Surgery · 66d
Cleared Aug 18, 2023
P200TE (A10700)
K231673 · OBO
Optos Plc.
Ophthalmic · 71d
Cleared Aug 18, 2023
SPARK Scan
K231457 · GWQ
Spark Neuro, Inc.
Neurology · 91d
Cleared Aug 18, 2023
Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia...
K231262 · HRS
Stryker GmbH
Orthopedic · 109d
Cleared Aug 18, 2023
Pangea Utility Plating System, Pangea Platform
K231257 · HRS
Stryker GmbH
Orthopedic · 109d
Cleared Aug 18, 2023
Cochlear™ Osia® System
K231204 · PFO
Cochlear
Ear, Nose, Throat · 113d
Cleared Aug 18, 2023
Automatic Continuous Effusion Shunt (ACES) System ACES System
K231096 · KPM
Pleural Dynamics, Inc.
Gastroenterology & Urology · 122d