Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
34321–34344 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 11, 2015
McKesson Cardiology
K151850 · LLZ
Mckesson Israel , Ltd.
Radiology · 35d
Cleared Aug 10, 2015
Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless...
K141594 · GCJ
Unimicro Medical Systems (Shenzhen)...
General & Plastic Surgery · 423d
Cleared Aug 10, 2015
Omega LIF System
K150395 · MAX
Amendia, Inc.
Orthopedic · 173d
Cleared Aug 10, 2015
Straumann Screw-Retained Abutment
K150814 · NHA
Straumann USA, LLC
Dental · 136d
Cleared Aug 10, 2015
Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides
K150928 · JWH
Materialise NV
Orthopedic · 126d
Cleared Aug 10, 2015
WASTON Metallic Bone Plate and Screw Systems
K151057 · HRS
Changzhou Waston Medical Appliance...
Orthopedic · 112d
Cleared Aug 10, 2015
Everest Spinal System
K151216 · NKB
K2m, Inc.
Orthopedic · 96d
Cleared Aug 10, 2015
NC Straumann Screw Retained Abutments
K151247 · NHA
Straumann USA, LLC
Dental · 91d
Cleared Aug 10, 2015
Restoration Anatomic Shell
K151264 · LPH
Stryker Orthopaedics
Orthopedic · 89d
Cleared Aug 10, 2015
Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens
K151586 · LPL
Yung Sheng Optical Co., Ltd.
Ophthalmic · 60d
Cleared Aug 07, 2015
LEECH, MEDICINAL
K140907 · NRN
Carolina Biological Supply Co.
General & Plastic Surgery · 486d
Cleared Aug 07, 2015
Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver
K143017 · FRO
Laboratoires Urgo
General & Plastic Surgery · 291d
Cleared Aug 07, 2015
PerioType Rapid
K143758 · DZE
Clinical House Europe GmbH
Dental · 219d
Cleared Aug 07, 2015
Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine...
K150022 · LCX
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 213d
Cleared Aug 07, 2015
Philips Spectral CT Applications
K150665 · JAK
Philips Medical Systems Nethrlands BV
Radiology · 144d
Cleared Aug 07, 2015
Assure Prism multi Blood Glucose Monitoring System
K151164 · NBW
I-Sens, Inc.
Chemistry · 98d
Cleared Aug 07, 2015
Synchro-Medical TIGER TRACK Screw System
K151241 · HWC
Synchro Medical
Orthopedic · 88d
Cleared Aug 07, 2015
syngo.MR Neurology, syngo.MR Oncology
K151353 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 79d
Cleared Aug 07, 2015
.decimal p.d
K151369 · MUJ
.Decimal, LLC
Radiology · 78d
Cleared Aug 07, 2015
Corvocet Coaxial Introducer
K151373 · FCG
Merit Medical Systems, Inc.
Gastroenterology & Urology · 78d
Cleared Aug 07, 2015
Selectra Catheters and Selectra Accessory Kit
K151409 · DQY
Biotronik, Inc.
Cardiovascular · 73d
Cleared Aug 07, 2015
Digital Automatic Wrist Blood Pressure Monitor MD3900
K151583 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 57d
Cleared Aug 07, 2015
Digital Automatic Wrist Blood Pressure Monitor MD3200
K151587 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 57d
Cleared Aug 07, 2015
8ch Foot Ankle Coil
K151653 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 50d