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
33793–33816 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 16, 2015
Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic...
K150037 · JAD
Sensus Healthcare
Radiology · 280d
Cleared Oct 16, 2015
PASS OCT Spinal System
K150918 · NKG
Medicrea International SA
Orthopedic · 193d
Cleared Oct 16, 2015
MIS Spine Frame Instrument Case
K151347 · KCT
Thompson Surgical Instruments
General Hospital · 149d
Cleared Oct 16, 2015
EV-820 OTC Pain Relief TENS
K151479 · NUH
Everyway Medical Instruments Co.,Ltd
Neurology · 136d
Cleared Oct 16, 2015
Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx,...
K151565 · OUY
Cepheid
Microbiology · 128d
Cleared Oct 16, 2015
ELTRAC 471
K151640 · ITH
Enraf-Nonius, B.V.
Physical Medicine · 120d
Cleared Oct 16, 2015
Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System,...
K151648 · NKB
Altus Partners, LLC
Orthopedic · 120d
Cleared Oct 16, 2015
Disposable Multistage Dilation Balloon Catheter
K151671 · FGE
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 116d
Cleared Oct 16, 2015
Rainbow Shade
K151844 · EIH
Genoss
Dental · 101d
Cleared Oct 16, 2015
GR40CW
K152094 · MQB
Samsung Electronics Co., Ltd.
Radiology · 80d
Cleared Oct 16, 2015
Terumo SurGuard 3 Safety Hypodermic Needle
K152362 · FMI
Terumo (Philippines) Corporation
General Hospital · 57d
Cleared Oct 16, 2015
Bladeless Optical Obturators
K152663 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 29d
Cleared Oct 16, 2015
Arm-Type Fully Automatic Digital Blood Pressure Monitor
K152687 · DXN
Sejoy Electronics & Instruments Co.,...
Cardiovascular · 28d
Cleared Oct 15, 2015
Aerobika OPEP Devive with Manometer
K150173 · BWF
Trudell Medical International
Anesthesiology · 262d
Cleared Oct 15, 2015
LigaSure Advance Monopolar Tip Laparoscopic Sealer/Divider, Pistol Grip
K150835 · GEI
Covidien
General & Plastic Surgery · 199d
Cleared CT Oct 15, 2015
AVERT Contrast Modulation System
K151300 · DXT
Osprey Medical, Inc.
Cardiovascular · 153d
Cleared Oct 15, 2015
MrOpen
K151466 · LNH
Paramed S.R.L.
Radiology · 136d
Cleared Oct 15, 2015
Visible Patient Suite
K151988 · LLZ
Visible Patient, Sas
Radiology · 90d
Cleared Oct 15, 2015
MONTAGE Settable, Resorbable Hemostatic Bone Putty
K152005 · MTJ
Orthocon, Inc.
General & Plastic Surgery · 87d
Cleared Oct 15, 2015
iSnare system-Lariat
K152035 · FBK
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 85d
Cleared Oct 15, 2015
LENSAR Laser System - fs 3D (LLS-fs 3D)
K152453 · OOE
Lensar, Inc.
Ophthalmic · 48d
Cleared Oct 15, 2015
Amendia Cervical Plate System
K152455 · KWQ
Amendia, Inc.
Orthopedic · 48d
Cleared Oct 15, 2015
Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar...
K152633 · LDF
Edwards Lifesciences, LLC
Cardiovascular · 30d
Cleared Oct 15, 2015
HammerFiX Device
K152710 · HWC
Extremity Medical, LLC
Orthopedic · 24d