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
5953–5976 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 27, 2024
Overjet Charting Assist
K241684 · QIH
Overjet, Inc.
Radiology · 77d
Cleared Aug 27, 2024
injeTAK Adjustable Tip Needle (DIS199
K241523 · FBK
Laborie Medical Technologies, Corp.
Gastroenterology & Urology · 90d
Cleared Aug 27, 2024
Q Guidance System
K241517 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 90d
Cleared Aug 27, 2024
Sealer Solvent
K241354 · KJJ
Inter-Med, Inc.
Dental · 106d
Cleared Aug 27, 2024
Z1 Cemented Hip System
K241241 · LZO
Orchard Medical Development, LLC
Orthopedic · 116d
Cleared Aug 27, 2024
TENSWave
K241228 · GZJ
Zynex Medical Officer
Physical Medicine · 117d
Cleared Aug 27, 2024
Electric wheelchair (S7018)
K240270 · ITI
Guangdong Prestige Technology Company...
Physical Medicine · 209d
Cleared Aug 27, 2024
Isolator Synergy EnCapture Ablation System (EMH)
K234151 · OCL
AtriCure, Inc.
Cardiovascular · 242d
Cleared Aug 27, 2024
Vitrification Solution Set and Warming Solution Set
K233846 · MQL
Ecmpc, LLC
Obstetrics & Gynecology · 267d
Cleared Aug 26, 2024
FiAPC plus probes
K242044 · GEI
Erbe Elektromedizin GmbH
General & Plastic Surgery · 45d
Cleared Aug 26, 2024
BARS Set (100.60)
K241858 · PKL
Ovesco Endoscopy AG
Gastroenterology & Urology · 60d
Cleared Aug 26, 2024
ulricheasyINJECT Max 2M (XD 10140)
K241850 · IZQ
Ulrich GmbH & Co. KG
General Hospital · 60d
Cleared Aug 26, 2024
SmartAdjust™ Technology
K241777 · QJI
Insulet Corporation
Chemistry · 67d
Cleared Aug 26, 2024
MyoStrain (6.0)
K241607 · LNH
Myocardial Solutions, Inc.
Radiology · 83d
Cleared Aug 26, 2024
TriClip Steerable Guide Catheter
K241538 · DQY
Abbott Medical
Cardiovascular · 88d
Cleared Aug 26, 2024
DESS Dental Smart Solutions
K240982 · NHA
Terrats Medical SL
Dental · 138d
Cleared Aug 26, 2024
PRIMED Surgical Masks and PRIMED Procedure Masks
K240286 · FXX
Primed Medical Products, Inc.
General Hospital · 207d
Cleared Aug 23, 2024
TMINI Miniature Robotic System
K242264 · OLO
THINK Surgical, Inc.
Orthopedic · 22d
Cleared Aug 23, 2024
LightWalker Laser System Family
K242202 · GEX
Fotona D.O.O.
General & Plastic Surgery · 28d
Cleared Aug 23, 2024
SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium...
K242191 · GEX
Olympus Surgical Technologies America
Gastroenterology & Urology · 29d
Cleared Aug 23, 2024
Morph DNA Steerable Introducer Sheath
K242169 · DYB
Biocardia
Cardiovascular · 30d
Cleared Aug 23, 2024
Cardinal Health Nitrile Exam Gloves
K241780 · LZA
Cardinal Health200, LLC
General Hospital · 64d
Cleared Aug 23, 2024
Guided Surgery Kit Cases
K241492 · KCT
JJGC Ind?stria e Com?rcio de...
General Hospital · 87d
Cleared Aug 23, 2024
SonoSync
K241302 · LLZ
Samsung Medison Co., Ltd.
Radiology · 106d