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
24793–24816 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 05, 2018
MAGNETOM Sola
K181322 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 140d
Cleared Oct 05, 2018
SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices
K181531 · MAX
Spineex, Inc.
Orthopedic · 116d
Cleared Oct 05, 2018
ORTHOLOC SPS Shoulder Plating System
K181587 · HRS
Tornier, Inc.
Orthopedic · 112d
Cleared Oct 05, 2018
EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT...
K181603 · NKG
K2m, Inc.
Orthopedic · 108d
Cleared CT Oct 05, 2018
B-Laser Atherectomy System
K181642 · MCW
Eximo Medical, Ltd.
Cardiovascular · 106d
Cleared Oct 05, 2018
Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model...
K181725 · PQK
Avenu Medical, Inc.
Cardiovascular · 98d
Cleared Oct 05, 2018
NuVasive Cohere Thoracolumbar Interbody System
K181860 · MAX
Nu Vasive, Incorporated
Orthopedic · 85d
Cleared Oct 05, 2018
SHINY RPL System
K181868 · ONF
Ids, Ltd.
General & Plastic Surgery · 85d
Cleared Oct 05, 2018
Sense System with IBT Electrodes
K182112 · GXY
Infinite Biomedical Technologies, LLC
Neurology · 60d
Cleared Oct 04, 2018
CURA 16
K173076 · JAK
Fmi Medical Systems, Inc.
Radiology · 370d
Cleared Oct 04, 2018
Diazyme 1,5-AG Assay
K180209 · NOZ
Diazyme Laboratories, Inc.
Chemistry · 253d
Cleared Oct 04, 2018
WishBone Medical Plate and Screw System
K180736 · HRS
Wishbone Medical, Inc.
Orthopedic · 196d
Cleared Oct 04, 2018
Rhino-Laryngo Fiberscope Olympus ENF-GP2
K181240 · EOB
Olympus Medical Systems Corp.
Ear, Nose, Throat · 147d
Cleared Oct 04, 2018
SYMPHONY™ OCT System
K181949 · NKG
Medos International SARL
Orthopedic · 76d
Cleared Oct 04, 2018
Prase MIS Spinal System
K182059 · NKB
Gbs Commonwealth Co., Ltd.
Orthopedic · 65d
Cleared Oct 04, 2018
Ureteric Catheters
K182122 · EYB
Coloplast Corp.
Gastroenterology & Urology · 59d
Cleared Oct 04, 2018
Encompass SRS Headframe
K182189 · IYE
Qfix
Radiology · 52d
Cleared Oct 04, 2018
HYBRID Guidewire
K182337 · MOF
Balt USA, LLC
Neurology · 37d
Cleared Oct 04, 2018
MAGLUMI 2000 FT4
K182423 · CEC
Shenzhen New Industries Biomedical...
Chemistry · 28d
Cleared Oct 04, 2018
POWEREASE System
K182436 · HBE
Medtronic Sofamor Danek USA, Inc.
Neurology · 27d
Cleared Oct 04, 2018
PIXX 1717
K182533 · MQB
Pixxgen Corporation
Radiology · 20d
Cleared Oct 03, 2018
ARIX Clavicle System
K180972 · HRS
Jeil Medical Corporation
Orthopedic · 173d
Cleared Oct 03, 2018
IS-III active System
K181138 · DZE
Neobiotech Co., Ltd.
Dental · 156d
Cleared Oct 03, 2018
Caretaker Remote Display App and Caretaker Software Library
K181196 · DRG
Caretaker Medical, LLC
Cardiovascular · 149d