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
23761–23784 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 11, 2019
Cemented TSI Hip Stem
K181340 · JDI
Signature Orthopaedics Pty, Ltd.
Orthopedic · 266d
Cleared Feb 11, 2019
SMG Anterior Cervical Plate System
K183073 · KWQ
Sapphire Medical Group
Orthopedic · 98d
Cleared Feb 11, 2019
BacT/ALERT FA Plus
K183166 · MDB
bioMerieux, Inc.
Microbiology · 88d
Cleared Feb 11, 2019
HANAROSTENT FASTTM Biliary (NNN)
K183396 · FGE
M.I. Tech Co., Ltd.
Gastroenterology & Urology · 66d
Cleared Feb 11, 2019
Athena II Cervical Plate System
K183409 · KWQ
Medyssey USA, Inc.
Orthopedic · 63d
Cleared Feb 11, 2019
easyPPHTM Hemorrhoidal Stapler for Single Use
K183477 · GDW
Ezisurg Medical Co., Ltd.
General & Plastic Surgery · 56d
Cleared Feb 11, 2019
Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion...
K183557 · ODP
Titan Spine, Inc.
Orthopedic · 53d
Cleared Feb 11, 2019
Elitone Device
K183585 · QAJ
Elidah, Inc.
Gastroenterology & Urology · 52d
Cleared Feb 11, 2019
IntraSight
K190078 · DSA
Volcano Corporation
Cardiovascular · 26d
Cleared Feb 11, 2019
Journey II Unicompartmental Knee System
K190085 · HSX
Smith & Nephew, Inc.
Orthopedic · 25d
Cleared Feb 08, 2019
SEKURE Acetaminophen L3K Assay
K180835 · LDP
Sekisui Diagnostics P.E.I., Inc.
Toxicology · 315d
Cleared Feb 08, 2019
Keeler TonoCare Tonometer
K181143 · HKX
Keeler Instruments, Inc.
Ophthalmic · 283d
Cleared Feb 08, 2019
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
K181317 · FDX
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 266d
Cleared Feb 08, 2019
Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance...
K181467 · CCK
Oridion Medical 1987 , Ltd.
Anesthesiology · 249d
Cleared Feb 08, 2019
Coala Heart Monitor
K182040 · DXH
Coala Life AB
Cardiovascular · 193d
Cleared Feb 08, 2019
ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ...
K182833 · EIH
The Argen Corporation
Dental · 122d
Cleared Feb 08, 2019
LINK MP Monoblock Hip Prosthesis
K183141 · LZO
Waldemar Link GmbH & Co. KG
Orthopedic · 87d
Cleared Feb 08, 2019
Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint...
K183186 · MOS
Shanghai United Imaging Healthcare...
Radiology · 81d
Cleared Feb 08, 2019
Carestream DRX-1 System with DRX Plus 2530 Detectors
K183245 · MQB
Carestream Health, Inc.
Radiology · 79d
Cleared Feb 08, 2019
Ammonia II
K183517 · JIF
Roche Diagnostics Operations (Rdo)
Chemistry · 52d
Cleared Feb 07, 2019
AcQMap High Resolution Imaging and Mapping System
K181577 · DQK
Acutus Medical, Inc.
Cardiovascular · 237d
Cleared Feb 07, 2019
SafeAir Smoke Evacuator compact
K182224 · FYD
Lina Medical Aps
General Hospital · 175d
Cleared Feb 07, 2019
Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal
K182259 · FTM
Acell, Inc.
General & Plastic Surgery · 170d
Cleared Feb 07, 2019
ROSA ONE Brain Application
K182417 · HAW
Medtech S.A
Neurology · 155d