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
7825–7848 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 22, 2024
Serafin®
K232074 · NXC
Tns Co., Ltd.
Dental · 225d
Cleared Feb 22, 2024
MultiPulse HoPLUS
K231876 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 241d
Cleared Feb 22, 2024
Vaginal Tactile Ultrasound Imager
K231875 · HIR
Advanced Tactile Imaging, Inc.
Obstetrics & Gynecology · 241d
Cleared Feb 22, 2024
NanoDrop Lancet
K223826 · FMK
Drawbridge Health, Inc.
General & Plastic Surgery · 428d
Cleared Feb 22, 2024
Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac
K214037 · ITH
Ergo-Flex Technologies, LLC
Physical Medicine · 791d
Cleared Feb 21, 2024
ProCinch, QuadCinch
K240194 · MBI
Riverpoint Medical
Orthopedic · 28d
Cleared Feb 21, 2024
HD60 Series Ultrasound Diagnostic System
K233439 · IYN
Qingdao Hisense Medical Equipment...
Radiology · 128d
Cleared Feb 21, 2024
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon...
K233325 · HQD
Visionary Optics, LLC
Ophthalmic · 145d
Cleared Feb 21, 2024
ROSA® Shoulder System
K233199 · OLO
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 146d
Cleared Feb 21, 2024
Cocoon Convective Warming System, Model CWS7000
K232502 · DWJ
Care Essentials Pty, Ltd.
Cardiovascular · 187d
Cleared Feb 21, 2024
BLUEPRINT™ Patient Specific Instrumentation
K232265 · PHX
Tornier S.A.S.
Orthopedic · 205d
Cleared Feb 21, 2024
X-Guide Surgical Navigation System
K232148 · QRY
X-Nav Technologies, LLC
Dental · 217d
Cleared Feb 21, 2024
Oneday Implant Abutment
K231753 · NHA
Oneday Biotech Co., Ltd.
Dental · 251d
Cleared Feb 21, 2024
Pulmonary Function Tester, Model: A9
K231561 · BTY
Guangzhou Homesun Medical Technology...
Anesthesiology · 266d
Cleared Feb 20, 2024
Mjolnir Pro. (Multi–electrode plasma)
K233760 · QVJ
Shenzhen Leaflife Technology Co., Ltd.
General & Plastic Surgery · 88d
Cleared Feb 20, 2024
Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120)
K233471 · NLQ
Stryker Sustainability Solutions
General & Plastic Surgery · 118d
Cleared Feb 20, 2024
ONLINE TDM Methotrexate
K233454 · LAO
Roche Diagnostics Operations
Toxicology · 123d
Cleared Feb 20, 2024
TS Abutment System
K233194 · NHA
Osstem Implant Co., Ltd.
Dental · 145d
Cleared Feb 20, 2024
NET BRAND Osteosynthesis Nailing System
K233150 · JDS
Narang Medical , Ltd.
Orthopedic · 146d
Cleared Feb 20, 2024
Diode Laser Therapy System
K231896 · GEX
Beijing Adss Development Co., Ltd.
General & Plastic Surgery · 237d
Cleared Feb 18, 2024
BD Prevue™ II Peripheral Vascular Access System
K240146 · IYO
Bard Access Systems, Inc.
Radiology · 30d
Cleared Feb 16, 2024
SCIg60 Infusion System
K240148 · PKP
Emed Technologies Corporation
General Hospital · 28d
Cleared Feb 16, 2024
Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System
K240137 · GXR
Neos Surgery S.L
Neurology · 29d
Cleared Feb 16, 2024
VasQ
K240119 · QVQ
Laminate Medical Technologies , Ltd.
Cardiovascular · 31d