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
11017–11040 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 27, 2023
GEM Premier ChemSTAT
K223090 · CGA
Instrumentation Laboratory CO
Chemistry · 119d
Cleared Jan 27, 2023
C2 Xplore
K223254 · ETN
Inomed Medizintechnik GmbH
Ear, Nose, Throat · 98d
Cleared Jan 27, 2023
14HQ721G-B
K223546 · MQB
Lg Electronics.Inc
Radiology · 63d
Cleared Jan 27, 2023
Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use...
K223903 · LZA
Semperit Investments Asia Pte , Ltd.
General Hospital · 30d
Cleared Jan 27, 2023
360CAS
K223927 · OLO
Kico Knee Innovation Company Pty Limited
Orthopedic · 28d
Cleared Jan 26, 2023
RMF-2000
K220073 · MUE
DRTECH Corporation
Radiology · 381d
Cleared Jan 26, 2023
Sterile Surgical Powder Free Latex Glove
K221424 · KGO
New Era Medicare Sdn. Bhd.
General Hospital · 255d
Cleared Jan 26, 2023
ECHELON Oval V6.2 MRI System
K221619 · LNH
Fujifilm Healthcare Corporation
Radiology · 237d
Cleared Jan 26, 2023
Ortho Device, ADAPTIX 3D Orthopedic Imaging System
K221949 · IZF
Pausch Medical GmbH
Radiology · 205d
Cleared Jan 26, 2023
Global Modular Replacement System, Modular Replacement System, Modular...
K222056 · JDI
Howmedica Osteonics Corp., Dba...
Orthopedic · 198d
Cleared Jan 26, 2023
Surgical Gown
K222403 · FYA
Guangzhou Fuzelong Hygiene Material...
General Hospital · 170d