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
29593–29616 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 22, 2017
My Dose Coach
K163099 · NDC
Sanofi, Inc.
General Hospital · 135d
Cleared Mar 22, 2017
OxyHeal 4000 Multiplace Hyperbaric Chamber Family
K163109 · CBF
Oxyheal Medical Systems, Inc.
Anesthesiology · 135d
Cleared Mar 22, 2017
ThermoShield HME Filter
K163300 · CAH
Flexicare Medical Limited.
General Hospital · 120d
Cleared Mar 22, 2017
HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit...
K170520 · MLZ
Alcon Research, Ltd.
Ophthalmic · 28d
Cleared Mar 22, 2017
Butrex Lumbar Buttress Plating System
K170530 · KWQ
X-Spine Systems, Inc.
Orthopedic · 28d
Cleared Mar 22, 2017
Fathom-16 Steerable Guidewires
K170636 · DQX
Boston Scientific Corporation
Cardiovascular · 20d
Cleared Mar 21, 2017
Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood...
K152534 · NBW
Tianjin Empecs Medical Device Co., Ltd.
Chemistry · 564d
Cleared Mar 21, 2017
MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)
K162740 · LTT
Beckman Coulter, Inc.
Microbiology · 172d
Cleared Mar 21, 2017
VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY...
K162758 · JOJ
STERIS Corporation
General Hospital · 172d
Cleared Mar 21, 2017
SmartGrid
K163157 · MQB
Carestream Health
Radiology · 131d
Cleared Mar 21, 2017
SOMATOM go.Up, SOMATOM go.Now
K163296 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 119d
Cleared Mar 21, 2017
LAP-Pump PP110
K163320 · HET
W.O.M. World of Medicine GmbH
Obstetrics & Gynecology · 118d
Cleared Mar 21, 2017
Icare HOME tonometer
K163343 · HKY
Icare Finland OY
Ophthalmic · 112d
Cleared Mar 21, 2017
Nix Ultra Lice Treatment Kit
K163401 · LJL
Medtech Products, Inc.
General Hospital · 106d
Cleared Mar 21, 2017
360KS Implant Positioning System
K163405 · LLZ
Kico Knee Innovation Company Pty Limited
Radiology · 106d
Cleared CT Mar 21, 2017
HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty...
K163608 · PST
Biostable Science & Engineering, Inc.
Cardiovascular · 90d
Cleared Mar 21, 2017
BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4-...
K163637 · LON
Becton, Dickinson Company
Microbiology · 88d
Cleared Mar 20, 2017
Luggie Chair
K160139 · ITI
Freerider Corporation
Physical Medicine · 424d
Cleared Mar 20, 2017
Phantom Fukushima Neurological Holding Systems, Phantom Mastability...
K161318 · GZT
Tedan Surgical Innovations, LLC
Neurology · 313d
Cleared Mar 20, 2017
Direct LDL Cholesterol (LDL)
K161691 · MRR
Randox Laboratories Limited
Chemistry · 273d
Cleared Mar 20, 2017
Sterile Single-use Syringe with Needle
K163161 · FMF
Jiangxi Hongda Medical Equipment...
General Hospital · 130d
Cleared Mar 20, 2017
Sterile Hypodermic Safety Syringes for Single Use
K163162 · MEG
Jiangxi Hongda Medical Equipment...
General Hospital · 130d
Cleared Mar 20, 2017
Bel-Cypher Pro
K163175 · MUH
Takara Belmont Corporation
Radiology · 126d
Cleared Mar 20, 2017
Dolphix® External Fixation System MR Conditional
K163323 · KTT
Citieffe S.R.L.
Orthopedic · 115d