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
5617–5640 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 07, 2024
GENESIS (MS-P02-GEN)
K240843 · ILK
Climbing Steps, Inc.
Physical Medicine · 194d
Cleared Oct 07, 2024
LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription...
K240485 · FRO
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 230d
Cleared Oct 06, 2024
Pangea Platform
K242445 · HRS
Stryker GmbH
Orthopedic · 51d
Cleared Oct 04, 2024
Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113,...
K242721 · DXN
Shenzhen Finicare Co., Ltd.
Cardiovascular · 24d
Cleared Oct 04, 2024
Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads...
K242679 · GDW
Fengh Medical Co., Ltd.
General & Plastic Surgery · 28d
Cleared Oct 04, 2024
Treace Medical Concepts (TMC) Screw Fixation System
K242671 · HWC
Treace Medical Concepts, Inc.
Orthopedic · 28d
Cleared Oct 04, 2024
Lunit INSIGHT DBT v1.1
K242652 · QDQ
Lunit, Inc.
Radiology · 30d
Cleared Oct 04, 2024
IdentiTi™ II Interbody System
K242364 · MAX
Alphatec Spine, Inc.
Orthopedic · 56d
Cleared Oct 04, 2024
Zeta Cranial Navigation System (ZNS131-US)
K242351 · HAW
Zeta Surgical, Inc.
Neurology · 57d
Cleared Oct 04, 2024
BPS Wrist Fracture System
K242343 · HRS
Orthonovis, Inc.
Orthopedic · 58d
Cleared Oct 04, 2024
GripTract-GI Endoscopic Tissue Manipulator Lower GI Models
K242325 · FDF
Actuated Medical, Inc.
Gastroenterology & Urology · 59d
Cleared Oct 04, 2024
AuST Steerable Sheath
K242106 · DYB
CenterPoint Systems, LLC
Cardiovascular · 78d
Cleared Oct 04, 2024
BioSieve™ Fentanyl FIA Home Test Kit
K241869 · NGL
Vivachek Biotech (Hangzhou) Co., Ltd.
Toxicology · 99d
Cleared Oct 04, 2024
Power Wheelchair
K241854 · ITI
Anhui Jbh Medical Apparatus Co., Ltd.
Physical Medicine · 99d
Cleared Oct 04, 2024
TroCare TroKit Laparoscope Lens Wiper (CP000626)
K241796 · GCJ
TroCare, LLC
General & Plastic Surgery · 105d
Cleared Oct 04, 2024
UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF
K241746 · JOW
United Medical Resources, LLC
Cardiovascular · 108d
Cleared Oct 04, 2024
Video Ureteroscope System
K241434 · FGB
Hunan Vathin Medical Instrument Co.,...
Gastroenterology & Urology · 136d
Cleared Oct 04, 2024
QUADSENSE
K241298 · ONN
Eventum Orthopaedics, Ltd.
Orthopedic · 149d
Cleared Oct 04, 2024
EchoSolv AS
K241245 · POK
Echo IQ, Ltd.
Radiology · 154d
Cleared Oct 04, 2024
Bladeless Trocar
K241052 · GCJ
Advamedix, GmbH
General & Plastic Surgery · 170d
Cleared Oct 04, 2024
Endoscopic Injection Needles
K240675 · FBK
Promisemed Hangzhou Meditech Co., Ltd.
Gastroenterology & Urology · 207d
Cleared Oct 04, 2024
LVivo Software Application
K240553 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 219d
Cleared Oct 04, 2024
Electroporation System (N3000)
K240376 · OAB
Surgnova Healthcare Technologies...
General & Plastic Surgery · 240d
Cleared Oct 04, 2024
Single use flexible ureteroscope (UR-D1)
K240074 · FGB
Shenzhen Besdata Technology Co., Ltd.
Gastroenterology & Urology · 268d