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
11281–11304 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 01, 2023
Certas Plus Programmable Valves
K223330 · JXG
Integra Lifesciences Production...
Neurology · 93d
Cleared Feb 01, 2023
Rapid RV/LV
K223396 · QIH
Ischemaview, Inc.
Radiology · 85d
Cleared Feb 01, 2023
BriefCase
K230020 · QFM
Aidoc Medical , Ltd.
Radiology · 29d
Cleared Jan 31, 2023
XBody Go USA, XBody Pro USA
K221200 · NGX
Xbody Hungary Kft.
Physical Medicine · 280d
Cleared Jan 31, 2023
V-SPERM WASH
K223117 · MQL
Vitromed GmbH
Obstetrics & Gynecology · 120d
Cleared Jan 31, 2023
Naviswiss Knee
K223351 · OLO
Naviswiss AG
Orthopedic · 90d
Cleared Jan 30, 2023
XChange Device, XChange System
K210112 · CCK
Pneuma Therapeutics, Inc.
Anesthesiology · 741d
Cleared Jan 30, 2023
PHMB Wound Dressing
K221532 · FRO
Winner Medical Co., Ltd.
General & Plastic Surgery · 249d
Cleared Jan 30, 2023
Playground For All Love Sesh
K222567 · NUC
Playground For All
Obstetrics & Gynecology · 159d
Cleared Jan 30, 2023
My3D® Personalized Pelvic Reconstruction
K223348 · LPH
Onkos Surgical, Inc.
Orthopedic · 89d
Cleared Jan 28, 2023
BrainView QEEG Software
K212684 · OLU
Medeia, Inc.
Neurology · 522d
Cleared Jan 27, 2023
Tacrolimus Assay Kit
K203833 · MLM
Shanghai Genext Medical Technology...
Chemistry · 758d
Cleared Jan 27, 2023
Omnispec ED1000
K210166 · ISA
Medispec, Ltd.
Physical Medicine · 736d
Cleared Jan 27, 2023
EasyStat 300
K211559 · CHL
Medica Corporation
Chemistry · 617d
Cleared Jan 27, 2023
Tibia and Fibula System
K213059 · HRS
Auxein Medical Private Limited
Orthopedic · 492d
Cleared Jan 27, 2023
VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP...
K220803 · LON
bioMerieux, Inc.
Microbiology · 315d
Cleared Jan 27, 2023
SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE...
K221306 · GEX
Gyrus Acmi, Inc.
Gastroenterology & Urology · 267d
Cleared Jan 27, 2023
F&P Airvo 3
K221338 · QAV
Fisher & Paykel Healthcare
Anesthesiology · 263d
Cleared Jan 27, 2023
FUJIFILM Endoscope Model EI-740D/S
K221551 · FDS
Fujifilm Corporaton
Gastroenterology & Urology · 241d
Cleared Jan 27, 2023
QOCA image Smart CXR Image Processing System
K221868 · QFM
Quanta Computer, Inc.
Radiology · 214d
Cleared Jan 27, 2023
Sim&Size
K222664 · PZO
Sim&Cure
Neurology · 147d
Cleared Jan 27, 2023
Prophecy Preoperative Navigation Alignment System
K222835 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 129d
Cleared Jan 27, 2023
EVA15 insufflator
K222901 · HIF
Palliare , Ltd.
Obstetrics & Gynecology · 126d
Cleared Jan 27, 2023
BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit
K223016 · PSZ
Bd
Microbiology · 120d