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
9745–9768 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 2023
Portable Oxygen Concentrator (Model: P2-E7, P2-E)
K223379 · CAW
Qingdao Kingon Medical Science and...
Anesthesiology · 227d
Cleared Jun 22, 2023
Straumann SLActive labeling changes
K223083 · DZE
Institut Straumann AG
Dental · 265d
Cleared Jun 22, 2023
INVOcell Intravaginal Culture System
K222932 · OYO
Invo Bioscience
Obstetrics & Gynecology · 269d
Cleared Jun 21, 2023
Habib EndoHPB
K231533 · KNS
Boston Scientific Corporation
Gastroenterology & Urology · 26d
Cleared Jun 21, 2023
Sturdy Autoclave Super Microm
K231489 · FLE
Sturdy Industrial Co., Ltd.
General Hospital · 29d
Cleared Jun 21, 2023
iLet® ACE Pump
K231485 · QFG
Beta Bionics, Inc.
Chemistry · 29d
Cleared Jun 21, 2023
PAXgene® Blood DNA Tube
K231469 · PJE
Preanalytix GmbH
Chemistry · 30d
Cleared Jun 21, 2023
1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF
K231467 · MQB
Rayence Co., Ltd.
Radiology · 30d
Cleared Jun 21, 2023
da Vinci E-200 Electrosurgical Generator
K231212 · GEI
Intuitive Surgical
General & Plastic Surgery · 54d
Cleared Jun 21, 2023
ACL TOP Family 70 Series
K231031 · GKP
Instrumentation Laboratory Company
Hematology · 71d
Cleared Jun 21, 2023
Connected OR Hub with Device and Voice Control
K230886 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 82d
Cleared Jun 21, 2023
PureLift Pro Edition
K230506 · NFO
Xtreem Pulse
Neurology · 117d
Cleared Jun 21, 2023
Intra-Operative Positioning System (IOPS®) (MC-1)
K230309 · DQK
Centerline Biomedical, Inc.
Cardiovascular · 138d
Cleared Jun 21, 2023
Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110)
K223376 · MEG
Cardinal Health200, LLC
General Hospital · 229d
Cleared Jun 21, 2023
Tablo® Hemodialysis System
K223248 · KDI
Outset Medical, Inc.
Gastroenterology & Urology · 243d
Cleared Jun 21, 2023
Tixel® 2 System
K223033 · GEI
Novoxel , Ltd.
General & Plastic Surgery · 265d
Cleared Jun 21, 2023
Accurate 24 Non-invasive blood pressure monitor
K222658 · DXN
Accurate Meditech, Inc.
Cardiovascular · 292d
Cleared Jun 21, 2023
Antibacterial Bandage
K221311 · FRO
Winner Medical Co., Ltd.
General & Plastic Surgery · 412d
Cleared Jun 20, 2023
HepaFatSmart (V2.0.0)
K231459 · LNH
Resonance Health Analysis Services...
Radiology · 32d
Cleared Jun 20, 2023
ScleroSafe™ 150 mm, ScleroSafe™ 350 mm
K231148 · KRA
Vvt Medical , Ltd.
Cardiovascular · 60d
Cleared Jun 20, 2023
Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)
K231075 · IZI
Carl Zeiss Meditec, Inc.
General & Plastic Surgery · 67d
Cleared Jun 20, 2023
CODA™ Anterior Cervical Plate System
K230993 · KWQ
Pioneer Surgical Technology, Inc...
Orthopedic · 75d
Cleared Jun 20, 2023
Sparrow Ascent
K230796 · PZR
Spark Biomedical, Inc.
Neurology · 90d
Cleared Jun 20, 2023
Belle Sensilube
K230781 · NUC
Rb Health (Us), LLC
Obstetrics & Gynecology · 90d