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
6721–6744 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 2024
Annabella Double Breast Pump (ADO-US23-1000)
K241506 · HGX
Annabella Tech
Obstetrics & Gynecology · 30d
Cleared Jun 27, 2024
MagnetOs Easypack Putty
K241212 · MQV
Kuros Biosciences
Orthopedic · 58d
Cleared Jun 27, 2024
The Optimotion™ Blue Plus Knee System
K240938 · MBH
Optimotion Implants, LLC
Orthopedic · 83d
Cleared Jun 27, 2024
Pathfinder® CR System
K240853 · FED
Neptune Medical, Inc.
Gastroenterology & Urology · 91d
Cleared Jun 27, 2024
els extra low shrinkage® composite & els extra low shrinkage® flow
K240823 · EBF
Saremco Dental AG
Dental · 93d
Cleared Jun 27, 2024
3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized...
K240717 · FRC
3M Company
General Hospital · 104d
Cleared Jun 27, 2024
NuFACE® FIX+
K240564 · NFO
Carol Cole Company Dba Nuface
Neurology · 119d
Cleared Jun 27, 2024
CATALYSTEM Femoral Stems
K240381 · LZO
Smith & Nephew, Inc.
Orthopedic · 140d
Cleared Jun 27, 2024
UNIKO PointCloud™ Knee Instruments
K240327 · JWH
Unik Orthopedics, Inc.
Orthopedic · 146d
Cleared Jun 27, 2024
Swan-Ganz Pacing Probe and Catheters
K233983 · DYG
Edwards Lifesciences
Cardiovascular · 192d
Cleared Jun 27, 2024
SteroScope® Sterilization Technology System
K233762 · MLR
Ideate Medical, Inc.
General Hospital · 216d
Cleared Jun 27, 2024
Faros Surgical System
K233398 · HQC
Oertli Instrumente AG
Ophthalmic · 268d
Cleared Jun 27, 2024
EsoCool Thermal Regulation Catheter
K233357 · PLA
Nuvaira, Inc.
Cardiovascular · 272d
Cleared Jun 26, 2024
ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK,...
K241507 · DTK
Aln S.A.R.L.
Cardiovascular · 29d
Cleared Jun 26, 2024
Magnifico Open (100009900)
K241133 · LNH
Esaote, S.P.A.
Radiology · 63d
Cleared Jun 26, 2024
Unity Knee PS-C Tibial Insert
K240875 · JWH
Corin U.S.A. Limited
Orthopedic · 89d
Cleared Jun 26, 2024
Forma Medical Optimal Plating System
K234059 · HRS
Forma Medical, Inc.
Orthopedic · 187d
Cleared Jun 26, 2024
Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)
K233840 · GCJ
Zhuhai Dipu Medical Technology Co., Ltd.
General & Plastic Surgery · 205d
Cleared Jun 26, 2024
SC1 Handheld Ultrasound Imaging system (Model: SC1)
K233579 · IYO
Fcu Co., Ltd.
Radiology · 232d
Cleared Jun 26, 2024
Ultraphon Chemical Indicator (TRO-T and TRO-B)
K233413 · JOJ
True Indicating, LLC
General Hospital · 264d
Cleared Jun 26, 2024
TRIDENT Mobile Fluoroscopy System
K233380 · JAA
Dornier Medtech America
Radiology · 268d
Cleared Jun 26, 2024
WVSM Pro (Series) (500-0030-XX)
K233354 · MWI
Athena Gtx, Inc.
Cardiovascular · 271d
Cleared Jun 26, 2024
FlowArt Valve for Vial Access
K232987 · LHI
Asset Medikal Tasarim Sanayi VE...
General Hospital · 278d
Cleared Jun 26, 2024
Versalock Rib and Sternum Plates System
K232829 · HRS
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 287d