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
25561–25584 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 2018
uDR 592h, uDR 596i
K181413 · KPR
Shanghai United Imaging Healthcare...
Radiology · 28d
Cleared Jun 26, 2018
Uterine Manipulator
K172846 · LKF
Beijing Hangtian Kadi Technology R&D...
Obstetrics & Gynecology · 280d
Cleared Jun 26, 2018
IV Administration Set
K173361 · FPA
B.Braun Medical, Inc.
General Hospital · 243d
Cleared Jun 26, 2018
DenSeeMammo
K173574 · LLZ
Statlife
Radiology · 218d
Cleared Jun 26, 2018
NeuMoDx GBS Assay
K173725 · NJR
Neumodx Molecular, Inc.
Microbiology · 203d
Cleared Jun 26, 2018
Express 4 Sleep appliance/CPAP Sidekick appliance
K173856 · LRK
Moses Appliances, LLC
Dental · 188d
Cleared Jun 26, 2018
SecurAcath
K180769 · OKC
Interrad Medical, Inc.
General Hospital · 95d
Cleared Jun 26, 2018
Range (Denali and Mesa) Spinal Systems
K181119 · NKB
K2m, Inc.
Orthopedic · 60d
Cleared Jun 26, 2018
Diazyme Human Kappa Free Light Chain Assay
K181438 · DFH
Diazyme Laboratories, Inc.
Immunology · 25d
Cleared Jun 25, 2018
MONET™ Anterior Cervical Interbody Fusion Cage System
K172788 · ODP
Ctl Medical Corporation
Orthopedic · 283d
Cleared Jun 25, 2018
EVOL® ha-C Cervical Interbody Fusion System
K180674 · ODP
Cutting Edge Spine, LLC
Orthopedic · 102d
Cleared Jun 25, 2018
Navigation Instruments
K180690 · OLO
Globus Medical, Inc.
Orthopedic · 101d
Cleared Jun 25, 2018
SafePath Suturing System
K180701 · GAP
Safepath Medical, Inc.
General & Plastic Surgery · 101d
Cleared Jun 25, 2018
SPIRA Open Matrix LLIF
K180724 · MAX
Camber Spine Technologies, LLC
Orthopedic · 97d
Cleared Jun 25, 2018
QUANTA Flash HMGCR Reagents
K180975 · LLL
Inova Diagnostics, Inc.
Immunology · 73d
Cleared Jun 25, 2018
Vscan Extend
K180995 · IYN
GE Medical Systems Ultrasound and...
Radiology · 70d
Cleared Jun 25, 2018
Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan...
K181230 · LPL
Largan Medical Co., Ltd.
Ophthalmic · 47d
Cleared Jun 25, 2018
EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay
K181329 · MSV
Phadia AB
Immunology · 38d
Cleared Jun 25, 2018
SpaceOAR System
K181465 · OVB
Augmenix, Inc.
Radiology · 21d
Cleared Jun 22, 2018
FIJI SUN FLUORESCENT TANNING UNIT
K151721 · LEJ
Kdb Inc. (Dba) Sperti Sunlamp
General & Plastic Surgery · 1093d
Cleared Jun 22, 2018
Perfadex Plus
K170826 · KDN
Xvivo Perfusion AB
Gastroenterology & Urology · 459d
Cleared Jun 22, 2018
Vios Monitoring System™ Model 2050
K172586 · DRT
Vios Medical, Inc.
Cardiovascular · 298d
Cleared Jun 22, 2018
AIROS 6 Sequential Compression Device
K172770 · JOW
Airos Medical, Inc.
Cardiovascular · 281d
Cleared Jun 22, 2018
AIROS 8 Sequential Compression Device
K172779 · JOW
Airos Medical, Inc.
Cardiovascular · 281d