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
11257–11280 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 03, 2023
14F iSLEEVE™ Introducer Set
K230051 · DYB
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Feb 03, 2023
Digital Flat Panel Detector
K230059 · MQB
Ray Imaging Technology (Haining) Limited
Radiology · 25d
Cleared Feb 02, 2023
S.E.A.L. Hemostatic Wound Spray
K210751 · QSY
Bc3 Technologies, Inc.
General & Plastic Surgery · 692d
Cleared Feb 02, 2023
Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869
K213545 · FLE
Steelco S.P.A.
General Hospital · 451d
Cleared Feb 02, 2023
Geonic Nasal Aspirator, Geonic Nasal Cleaner
K220126 · BTA
Geon Corporation
Ear, Nose, Throat · 380d
Cleared Feb 02, 2023
Wee Bell
K221356 · HFX
Wee Medical
Obstetrics & Gynecology · 268d
Cleared Feb 02, 2023
StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible...
K221515 · FGB
Boston Scientific Corporation
Gastroenterology & Urology · 253d
Cleared Feb 02, 2023
Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH
K221781 · GCJ
Guangdong Optomedic Technologies, Inc.
General & Plastic Surgery · 226d
Cleared Feb 02, 2023
Implant Direct Dental Implant Systems Portfolio - MR Conditional
K222211 · DZE
Implant Direct Sybron Manufacturing, LLC
Dental · 192d
Cleared Feb 02, 2023
Polaris Valve Electronic Reading Instrument
K222422 · JXG
Sophysa
Neurology · 175d
Cleared Feb 02, 2023
DeltaScan Patch
K222671 · GXY
Prolira B.V.
Neurology · 149d
Cleared Feb 02, 2023
DeltaScan Monitor
K222680 · NCG
Prolira B.V.
Neurology · 149d
Cleared Feb 02, 2023
Oncospace
K222803 · MUJ
Oncospace, Inc.
Radiology · 139d
Cleared Feb 02, 2023
SutureLoc™ Implant
K223284 · MBI
Arthrex, Inc.
Orthopedic · 100d
Cleared Feb 02, 2023
Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device
K223362 · OVE
4Web Medical, Inc.
Orthopedic · 91d
Cleared Feb 02, 2023
SmartRelease Endoscopic Soft Tissue Release System
K223406 · HRX
Microaire Surgical Instruments
General Hospital · 85d
Cleared Feb 02, 2023
PreView-III™ Anterior Cervical Plate System
K223627 · KWQ
Nexus Spine, LLC
Orthopedic · 59d
Cleared Feb 02, 2023
Atomica Planner
K230012 · LLZ
Atomica Technology, Inc.
Radiology · 30d
Cleared Feb 01, 2023
31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil
K213480 · MOS
Rapid Biomedical GmbH
Radiology · 460d
Cleared Feb 01, 2023
Tinnitogram Signal Generator
K221168 · KLW
Goldenear Company, Inc.
Ear, Nose, Throat · 285d
Cleared Feb 01, 2023
EmbedMed
K221943 · PBF
3D Lifeprints UK , Ltd.
Orthopedic · 211d
Cleared Feb 01, 2023
LED Light Therapy Device, KN-7000L
K222751 · GEX
Xuzhou Kernel Medical Equipment Co.,...
General & Plastic Surgery · 142d
Cleared Feb 01, 2023
Garment Electrodes
K222863 · GXY
Tone-A-Matic International, Inc.
Neurology · 132d
Cleared Feb 01, 2023
LVivo IQS
K222970 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 127d