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

Filters: Cleared only ×
175,820 results
36601–36624 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 19, 2014
Arthrex iBalance Patella Implant, Dome
K143047 · JWH
Arthrex, Inc.
Orthopedic · 27d
Cleared Nov 18, 2014
J-SCREW COMPRESSION SCREW
K130019 · HWC
Competitive Engineering, Inc.
Orthopedic · 684d
Cleared Nov 18, 2014
UNEXEF-38G ULTRASOUND SYSTEM
K131973 · IYN
Toyota Tsusho Corporation
Radiology · 508d
Cleared Nov 18, 2014
UNIVERSA PERCULTANEOUS DRAINAGE CATHETER
K140085 · FEW
Cook Incorporated
Gastroenterology & Urology · 309d
Cleared Nov 18, 2014
TRACTION POLYPECTOMY SNARE
K140923 · FDI
Ovesco Endoscopy AG
Gastroenterology & Urology · 222d
Cleared Nov 18, 2014
AEQUALIS FX2
K141345 · PHX
Tornier S.A.S.
Orthopedic · 180d
Cleared Nov 18, 2014
INTERMITTENT PNEUMATIC COMPRESSION DEVICE
K141390 · JOW
Wuhan Landing Medical Hi-Tech, Ltd.
Cardiovascular · 175d
Cleared Nov 18, 2014
RESCAN 700, CALLISTO EYE
K141844 · OBO
Carl Zeiss Meditec, AG
Ophthalmic · 133d
Cleared Nov 18, 2014
ERB ENDORECTAL BALLOON
K141958 · PCT
Edge Medical, LLC
Radiology · 123d
Cleared Nov 18, 2014
TRANSOM ANTERIOR CERVICAL PLATE
K142060 · KWQ
Neurostructures, Inc.
Orthopedic · 112d
Cleared Nov 18, 2014
LessRay with Tracking
K142243 · OWB
Saferay Spine, LLC
Radiology · 97d
Cleared Nov 18, 2014
Amedica Valeo II Interbody Fusion Device
K142347 · MAX
Amedica Corp.
Orthopedic · 88d
Cleared Nov 18, 2014
Vertical Expandable Prosthetic Titanium Rib
K142587 · MDI
Depuy Synthes Spine, Inc.
Orthopedic · 64d
Cleared Nov 18, 2014
Bio-Medicus Adult Cannulae and Introducer
K142673 · DWF
Medtronic, Inc.
Cardiovascular · 60d
Cleared Nov 18, 2014
3MP Color LCD monitor, RadiForce RS340
K143098 · PGY
Eizo Corporation
Radiology · 21d
Cleared Nov 18, 2014
Sentinella 102
K143156 · IYX
General Equipment For Medical Imaging...
Radiology · 15d
Cleared Nov 17, 2014
A-LINK Z
K133827 · OVD
Osteo Vasive, LLC
Orthopedic · 335d
Cleared Nov 17, 2014
SAIPH KNEE SYSTEM
K140222 · JWH
Matortho
Orthopedic · 292d
Cleared Nov 17, 2014
ASCEND ELECTRODE
K140586 · GXY
Neurometrix, Inc.
Neurology · 255d
Cleared Nov 17, 2014
THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM
K140595 · FDF
Avantis Medical Systems, Inc.
Gastroenterology & Urology · 255d
Cleared Nov 17, 2014
CLINITEK NOVUS
K140717 · KQO
Siemens Healthcare Diagnostics
Chemistry · 242d
Cleared Nov 17, 2014
ZIP MIS INTERSPINOUS FUSION SYSTEM
K141317 · PEK
Aurora Spine, Inc.
Orthopedic · 181d
Cleared Nov 17, 2014
SURGICAL GOWN
K141606 · FYA
Cobes Industries Co., Ltd.
General Hospital · 154d
Cleared Nov 17, 2014
PREMIER ETCH
K141839 · KLE
Premier Dental Products Co.
Dental · 132d