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
30241–30264 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 30, 2016
Cranial Reducing Tubes
K162604 · HAW
Medtronic Navigation, Inc.
Neurology · 102d
Cleared Dec 30, 2016
Teeter Manual Inversion Table
K162702 · HST
Stl International, Inc.
Neurology · 93d
Cleared Dec 30, 2016
MultiBand SENSE
K162940 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 70d
Cleared Dec 29, 2016
Disposable Insulin Syringe
K162180 · FMF
Berpu Medical Technology Co., Ltd.
General Hospital · 147d
Cleared Dec 29, 2016
Envision 3D: Image Guidance System
K162375 · OLO
7D Surgical, Inc.
Orthopedic · 127d
Cleared Dec 29, 2016
STERISPINE CC
K162531 · OVE
Safe Orthopaedics
Orthopedic · 111d
Cleared Dec 29, 2016
Hubble II
K163180 · MAX
Orbbo Surgical, LLC
Orthopedic · 45d
Cleared Dec 28, 2016
Gexfix External Fixation
K160972 · KTT
Gexfix International Corp.
Orthopedic · 266d
Cleared Dec 28, 2016
Hang&Go PAC
K161613 · LGZ
Rand S.R.L.
General Hospital · 201d
Cleared Dec 28, 2016
ClearView cCAD
K161959 · LLZ
Clearview Diagnostics, Inc.
Radiology · 163d
Cleared Dec 28, 2016
Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter
K162675 · DQA
Masimo Corporation
Anesthesiology · 93d
Cleared Dec 28, 2016
Kuschall Champion Manual Wheelchair
K162686 · IOR
Invacare Corporation
Physical Medicine · 92d
Cleared Dec 28, 2016
Kuschall K-Series Attract Manual Wheelchair
K162692 · IOR
Invacare Corporation
Physical Medicine · 92d
Cleared Dec 28, 2016
Kuschall Advance Manual Wheelchair
K162696 · IOR
Invacare Corporation
Physical Medicine · 92d
Cleared Dec 28, 2016
Medline ReNewal Reprocessed Stryker External Fixation Devices
K163028 · JEC
Surgical Instrument Service and...
Orthopedic · 58d
Cleared Dec 27, 2016
BLUEPRINT Patient Specific Instrumentation
K161789 · KWS
Tornier S.A.S.
Orthopedic · 181d
Cleared Dec 27, 2016
SMARTO
K163308 · KIJ
Jeil Medical Corporation
Orthopedic · 34d
Cleared Dec 26, 2016
Sysmex CS-2100i
K162688 · JPA
Siemens Healthcare Diagnostics...
Hematology · 90d
Cleared CT Dec 23, 2016
Model X-100C CO-Met™ Oximetry System
K160231 · DQA
Nonin Medical, Inc.
Anesthesiology · 326d
Cleared Dec 23, 2016
BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring...
K161299 · NBW
Apex BioTechnology Corp.
Chemistry · 228d
Cleared Dec 23, 2016
XenMatrix AB Surgical Graft
K162193 · PIJ
C. R. Bard
General & Plastic Surgery · 141d
Cleared Dec 23, 2016
Kurin Blood Culture Collection Set
K162233 · JKA
Pathway, LLC
Chemistry · 137d
Cleared Dec 23, 2016
ARIES GBS Assay
K162772 · NJR
Luminex Corporation
Microbiology · 81d
Cleared Dec 23, 2016
AMPLATZER TorqVue 45x45 Delivery Sheath
K163000 · DQY
Aga Medical COrporation (Wholly Owned...
Cardiovascular · 56d