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
2065–2088 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 2025
prolaio eVO2peak Module (Version 1.0)
K252204 · PPW
Prolaio, Inc.
Cardiovascular · 155d
Cleared Dec 16, 2025
Versius Surgical System (Versius Plus)
K252111 · SCV
Cmr Surgical Limited
General & Plastic Surgery · 162d
Cleared Dec 16, 2025
Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3,...
K251951 · FGB
Guangzhou Red Pine Medical Instrument...
Gastroenterology & Urology · 174d
Cleared Dec 16, 2025
SKAN C PULSAR
K251893 · OWB
Skanray Technologies Limited
Radiology · 179d
Cleared Dec 16, 2025
Cambridge Partial Knee
K251771 · HSX
Signature Orthopaedics Pty, Ltd.
Orthopedic · 189d
Cleared Dec 16, 2025
IRISeg
K251763 · QIH
Intuitive Surgical, Inc.
Radiology · 190d
Cleared Dec 16, 2025
Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
K251745 · DXQ
Baxter Healthcare Corporation
Cardiovascular · 193d
Cleared Dec 16, 2025
PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family)
K251256 · FDS
Pentax of America, Inc.
Gastroenterology & Urology · 237d
Cleared Dec 16, 2025
ADVIA Centaur Cytokeratin Fragment 21-1
K250925 · OVK
Fujirebio Diagnostics,Inc.
Immunology · 264d
Cleared Dec 15, 2025
V•Stick™ Vascular Access Set
K253741 · DYB
Argon Medical Devices, Inc.
Cardiovascular · 21d
Cleared Dec 15, 2025
Tembo Embolic System
K253677 · KRD
Instylla, Inc.
Cardiovascular · 24d
Cleared Dec 15, 2025
FemVue® Controlled Saline-Air Device (FSA-300)
K253403 · LKF
Femasys, Inc.
Obstetrics & Gynecology · 76d
Cleared Dec 15, 2025
HyperVue™ Imaging System - Integrated
K253101 · NQQ
Spectrawave, Inc.
Cardiovascular · 82d
Cleared Dec 15, 2025
Paradigm System
K252950 · OLO
Proprio, Inc.
Orthopedic · 90d
Cleared Dec 15, 2025
Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml,...
K252935 · NUC
Foshan Pingchuang Medical Technology...
Obstetrics & Gynecology · 91d
Cleared Dec 15, 2025
Triathlon® Tritanium® Asymmetric Patella
K252898 · KRO
Howmedica Osteonics Corp., Dba...
Orthopedic · 95d
Cleared Dec 15, 2025
da Vinci SP Surgical System (SP1098)
K252675 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 112d
Cleared Dec 15, 2025
Erchonia CLX (Model # CFL)
K252574 · OLI
Erchonia Corporation
General & Plastic Surgery · 123d
Cleared Dec 15, 2025
SleepRes PAP System
K251770 · BZD
Sleepres, Inc.
Anesthesiology · 188d
Cleared Dec 15, 2025
OptiMesh Multiplanar Expandable Interbody Fusion System
K251302 · OQB
Spineology, Inc.
Orthopedic · 231d
Cleared Dec 15, 2025
MFUSE (MS001)
K250319 · QSY
Machina Medical, Inc.
General & Plastic Surgery · 314d
Cleared Dec 14, 2025
Hypnos (369054-200)
K250851 · OLZ
Cadwell Industries, Inc.
Neurology · 268d
Cleared Dec 12, 2025
Affixus® Natural Nail® Proximal Humeral System
K253749 · HSB
Zimmer Switzerland Manufacturing GmbH
Orthopedic · 17d
Cleared Dec 12, 2025
TRAUMAGEL® 2.0 Hemostatic Gel
K253609 · QSY
Cresilon, Inc.
General & Plastic Surgery · 24d