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
33553–33576 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 2015
Radifocus Glidewire
K152740 · DQX
Ashitaka Factory of Terumo Corp.
Cardiovascular · 54d
Cleared Nov 16, 2015
UroNav (Version 2.0)
K153073 · LLZ
Invivo Corporation
Radiology · 25d
Cleared Nov 13, 2015
BTL-4000
K150353 · IMG
BTL Industries, Inc.
Physical Medicine · 275d
Cleared Nov 13, 2015
ComboRehab
K150436 · IMG
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine · 267d
Cleared Nov 13, 2015
Humelock II Reversible Shoulder System
K150488 · PHX
Fx Solutions
Orthopedic · 261d
Cleared Nov 13, 2015
MAKO Device
K151275 · HIH
Nvision Medical
Obstetrics & Gynecology · 184d
Cleared Nov 13, 2015
Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter
K151638 · DQY
Cathera, Inc.
Cardiovascular · 149d
Cleared Nov 13, 2015
AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access...
K151667 · DQY
Stryker
Cardiovascular · 147d
Cleared Nov 13, 2015
Polaris Spinal System
K151974 · NKB
Biomet Spine
Orthopedic · 120d
Cleared Nov 13, 2015
Denture base resin
K152270 · EBI
Korea Engineering Plastics Co., Ltd.
Dental · 94d
Cleared Nov 13, 2015
PIVOX(tm) Oblique Lateral Spinal System
K152277 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 93d
Cleared Nov 13, 2015
Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
K152723 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 52d
Cleared Nov 13, 2015
SIGN Hip Construct (SHC)
K152757 · HSB
Sign Fracture Care International
Orthopedic · 50d
Cleared Nov 13, 2015
Multitom Rax
K152928 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 39d
Cleared Nov 13, 2015
Sirius Max Dental Diode Curing Light
K152936 · EBZ
National Dental, Inc.
Dental · 39d
Cleared Nov 13, 2015
LithoVue System
K153049 · FGB
Boston Scientific Corporation
Gastroenterology & Urology · 24d
Cleared Nov 13, 2015
Klassic Knee System
K153075 · JWH
Total Joint Orthopedics, Inc.
Orthopedic · 21d
Cleared Nov 12, 2015
Entropy Module, E-ENTROPY-01
K150298 · OLW
Ge Healthcare Filand OY
Neurology · 279d
Cleared Nov 12, 2015
Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test...
K150358 · GMQ
Gold Standard Diagnostics
Microbiology · 273d
Cleared Nov 12, 2015
Dental Implant System
K150388 · DZE
Bio Concept Co., Ltd.
Dental · 267d
Cleared Nov 12, 2015
Eclipse System
K150558 · PJH
Pelvalon, Inc.
Gastroenterology & Urology · 253d
Cleared Nov 12, 2015
Water Based Personal Lubricant with Flavours
K150743 · NUC
Karex Industries Sdn. Bhd.
Obstetrics & Gynecology · 234d
Cleared Nov 12, 2015
Valved Safety Centesis Catheter
K150800 · GCB
B.Braun Medical, Inc.
General & Plastic Surgery · 231d
Cleared Nov 12, 2015
SOMATOM Emotion 6/16
K151752 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 136d