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
19105–19128 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 2020
Precice® Ankle Salvage System
K200430 · HSB
Nuvasive Specialized Orthopedics, Inc.
Orthopedic · 208d
Cleared Sep 16, 2020
PAPAYA 3D Premium & PAPAYA 3D Premium Plus
K200469 · OAS
Genoray Co., Ltd.
Radiology · 203d
Cleared Sep 16, 2020
VX1
K201298 · DQK
Volta Medical
Cardiovascular · 124d
Cleared Sep 16, 2020
AVA (Augmented Vascular Analysis)
K201369 · LLZ
See-Mode Technologies Pte, Ltd.
Radiology · 117d
Cleared Sep 16, 2020
Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set
K201661 · OLO
Medos International SARL
Orthopedic · 90d
Cleared Sep 16, 2020
Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential...
K201774 · KGO
Pt. Medisafe Technologies
General Hospital · 79d
Cleared Sep 16, 2020
Tulsa-Pro System
K202286 · PLP
Profound Medical, Inc.
Gastroenterology & Urology · 35d
Cleared Sep 16, 2020
Ziehm Vision RFD 3D
K202360 · OWB
Ziehm Imaging GmbH
Radiology · 28d
Cleared Sep 16, 2020
EOSedge
K202394 · KPR
Eos Imaging
Radiology · 26d
Cleared Sep 16, 2020
Butterfly iQ Ultrasound System
K202406 · IYN
Butterfly Network, Inc.
Radiology · 26d
Cleared Sep 15, 2020
Accelerate Pheno System, Accelerate PhenoTest BC Kit
K192665 · PRH
Accelerate Diagnostics, Inc.
Microbiology · 356d
Cleared Sep 15, 2020
Athletis PTA Balloon Dilatation Catheter
K201170 · LIT
Boston Scientific Corporation
Cardiovascular · 137d
Cleared Sep 15, 2020
AcQMap 3D Imaging and Mapping Catheter
K201341 · MTD
Acutus Medical, Inc.
Cardiovascular · 118d
Cleared Sep 15, 2020
Massage Compression Boots
K201645 · IRP
Jkh USA, LLC
Physical Medicine · 90d
Cleared Sep 15, 2020
ARIX Elbow System
K201656 · HRS
Jeil Medical Corporation
Orthopedic · 89d
Cleared Sep 15, 2020
FIREBIRD SI Fusion System
K201664 · OUR
Orthofix, Inc.
Orthopedic · 88d
Cleared Sep 15, 2020
Collaboration Live
K201665 · LLZ
Philips Ultrasound, Inc.
Radiology · 88d
Cleared Sep 15, 2020
UNIFUSE Infusion System with Cooper Wire
K202347 · QEY
AngioDynamics, Inc.
Cardiovascular · 28d
Cleared Sep 14, 2020
VIVO
K200313 · DQK
Catheter Precision, Inc.
Cardiovascular · 221d
Cleared Sep 14, 2020
FusionFrame Ring Lock System
K200343 · KTT
Glw Medical Innovation
Orthopedic · 216d
Cleared Sep 14, 2020
Feelix Stethoscope
K200862 · DQD
Sonavi Labs, Inc.
Cardiovascular · 166d
Cleared Sep 14, 2020
VersaWrap Nerve Protector
K201631 · JXI
Alafair Biosciences, Inc.
Neurology · 90d
Cleared Sep 14, 2020
Shoreline ACS (Anterior Cervical System)
K201646 · OVE
SeaSpine Orthopedics Corporation
Orthopedic · 89d
Cleared Sep 14, 2020
Artus™ cervical plate system
K202227 · KWQ
Ulrich GmbH & Co. KG
Orthopedic · 38d