FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
16009–16032 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 07, 2021
Digital Intraoral X-ray Imaging System
K212279 · MUH
Iray Technology Taicang , Ltd.
Radiology · 79d
Cleared Oct 07, 2021
SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack...
K212860 · FDI
STERIS Corporation
Gastroenterology & Urology · 29d
Cleared Oct 06, 2021
TrusFIL Universal Composite Restorative
K202063 · EBF
Rizhao Huge Biomaterials Company, Ltd.
Dental · 436d
Cleared Oct 06, 2021
Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)
K211621 · KGO
Careplus (M) Sdn Bhd
General Hospital · 133d
Cleared Oct 06, 2021
ZinRom Nitrile examination gloves
K211719 · LZA
Changzhou Xingrong Medical Technology...
General Hospital · 124d
Cleared Oct 06, 2021
Picore
K212082 · GEX
Bio-Med USA, Inc.
General & Plastic Surgery · 96d
Cleared Oct 06, 2021
Adhesive Electrodes
K212191 · GXY
Voncare Medical Device Co., Ltd.
Neurology · 86d
Cleared Oct 06, 2021
ActiFlip
K212739 · MBI
Parcus Medical, LLC
Orthopedic · 37d
Cleared Oct 06, 2021
AquaBeam Robotic System
K212835 · PZP
Procept Biorobotics, Corporation
Gastroenterology & Urology · 29d
Cleared Oct 05, 2021
CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood...
K201394 · NBW
I-Sens, Inc.
Chemistry · 496d
Cleared CT Oct 05, 2021
Scan Monitor
K201456 · DPS
Withings SA
Cardiovascular · 491d
Cleared Oct 05, 2021
SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle...
K203002 · HRS
Bonebridge AG
Orthopedic · 369d
Cleared Oct 05, 2021
Cala Trio
K203288 · QBC
Cala Health, Inc.
Neurology · 330d
Cleared Oct 05, 2021
Bipolar Coagulation Foreceps
K210406 · KGE
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 237d
Cleared Oct 05, 2021
ChM 4.5mm Cortical screws
K210490 · HWC
Chm Sp. Z O.O.
Orthopedic · 228d
Cleared Oct 05, 2021
NAVIPLAN - CT Planning Software for Total Hip Replacement
K211429 · LLZ
Naviswiss AG
Radiology · 151d
Cleared Oct 05, 2021
Vital Signs Monitors
K211475 · MWI
Shenzhen Mindray Bio-Medical...
Cardiovascular · 146d
Cleared Oct 05, 2021
Steinmann Pins and Kirschner Wires
K211508 · JDW
Stryker GmbH
Orthopedic · 144d
Cleared Oct 05, 2021
Sterile hypodermic syringes for single use
K211728 · FMF
Jiangsu Kangyou Medical Instrument...
General Hospital · 123d
Cleared Oct 05, 2021
Nitrile Powder Free Examination Gloves,Tested For Use With Chemotherapy Drugs
K212036 · LZA
Jiangsu Yanfang Medical Technology...
General Hospital · 97d
Cleared Oct 05, 2021
RTHawk, HeartVista Cardiac Package
K212233 · LNH
Heartvista, Inc.
Radiology · 81d
Cleared Oct 04, 2021
Smart Neck Stimulator
K200558 · NUH
Guandong Skg Intelligent Technology...
Neurology · 580d
Cleared CT Oct 04, 2021
VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack
K201312 · NBC
Ortho-Clinical Diagnostics
Chemistry · 504d
Cleared Oct 04, 2021
INNI-CERA
K211308 · EIH
Aon Co., Ltd.
Dental · 158d