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
9385–9408 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 02, 2023
Immunoglobulin G (IgG)
K221114 · CFN
Beckman Coulter Laboratory Systems...
Immunology · 474d
Cleared Aug 01, 2023
REAL INTELLIGENCE™ CORI™
K231963 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 29d
Cleared Aug 01, 2023
EXPD 4357
K231959 · MQB
DRTECH Corporation
Radiology · 29d
Cleared Aug 01, 2023
Aristotle 18 Guidewire
K231954 · MOF
Scientia Vascular, Inc.
Neurology · 29d
Cleared Aug 01, 2023
Nuubo Smart
K231620 · DQK
Smart Solutions Technologies SL
Cardiovascular · 60d
Cleared Aug 01, 2023
Protego Air Water Connector
K231602 · OCX
Ga Health Company Limited
Gastroenterology & Urology · 61d
Cleared Aug 01, 2023
Knotless Suture Anchor
K231278 · MBI
Riverpoint Medical, LLC
Orthopedic · 90d
Cleared Aug 01, 2023
Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments
K230873 · NHA
Southern Implants (Pty), Ltd.
Dental · 124d
Cleared Aug 01, 2023
uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy...
K230162 · JAK
Shanghai United Imaging Healthcare...
Radiology · 193d
Cleared Jul 31, 2023
Altris IMS
K232088 · NFJ
Altris, Inc.
Ophthalmic · 18d
Cleared Jul 31, 2023
AllTest Fentanyl Rapid Test (Urine)
K231698 · DJG
Hangzhou AllTest Biotech Co., Ltd.
Toxicology · 49d
Cleared Jul 31, 2023
Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G,...
K231613 · OHT
Zhuzhou Goldenhot Medical Technology...
General & Plastic Surgery · 59d
Cleared Jul 31, 2023
V-Print c&b temp
K231591 · POW
Voco GmbH
Dental · 60d
Cleared Jul 31, 2023
Nooance Led And Laser Helmet
K231321 · OAP
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 84d
Cleared Jul 31, 2023
BD Respiratory Viral Panel for BD MAX™ System
K230956 · QOF
Bd Integrated Diagnostic Solutions /
Microbiology · 118d
Cleared Jul 31, 2023
QUATERA 700
K230858 · HQC
Carl Zeiss Meditec, AG
Ophthalmic · 124d
Cleared Jul 31, 2023
ZENEX Implant System_Narrow
K230630 · DZE
Izenimplant Co., Ltd.
Dental · 146d
Cleared Jul 31, 2023
Disposable Hemoclip
K230004 · PKL
Yangzhou Fartley Medical Instrument...
Gastroenterology & Urology · 209d
Cleared Jul 31, 2023
CNS-2101 Central Monitor
K223567 · MSX
Nihon Kohden Corporation
Cardiovascular · 244d
Cleared Jul 31, 2023
RenaNav Ureteroscope System
K223097 · FGB
CenterPoint Systems, LLC
Gastroenterology & Urology · 304d
Cleared Jul 31, 2023
Surgical Sutures with or without Needle
K221767 · GAP
Huaian Seamen Medical Technology Co.,...
General & Plastic Surgery · 409d
Cleared Jul 30, 2023
SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC
K222862 · GEX
Lotuxs Medtech (Suzhou) Co., Ltd.
General & Plastic Surgery · 311d
Cleared Jul 28, 2023
SI-Cure Sacroiliac Joint Fusion System
K231951 · OUR
Alevio, LLC
Orthopedic · 28d
Cleared Jul 28, 2023
Adena-Zina Spinal System
K231931 · NKB
Shanghai Sanyou Medical Co, Ltd.
Orthopedic · 28d