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
32353–32376 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 11, 2016
Winco Model S550 Stretchair
K152056 · INK
Winco Manufacturing, LLC
Physical Medicine · 262d
Cleared Apr 11, 2016
HemiCAP MTP Resurfacing Hemi-Arthroplasty System
K152454 · KWD
Arthrosurface, Inc.
Orthopedic · 227d
Cleared Apr 11, 2016
LifeGlobal Micro Tips
K152581 · MQH
Life Global Group, LLC
Obstetrics & Gynecology · 214d
Cleared Apr 11, 2016
TREFOIL System
K152836 · DZE
Nobel Biocare AB
Dental · 195d
Cleared Apr 11, 2016
BioMonitor 2-AF, BioMonitor 2-S
K152995 · MXD
Biotronik, Inc.
Cardiovascular · 181d
Cleared Apr 11, 2016
Noris Medical MBI Dental Implant System
K153043 · DZE
Noris Medical , Ltd.
Dental · 175d
Cleared Apr 11, 2016
Hoffmann LRF (Limb Reconstruction Frame) System
K153377 · KTT
Stryker GmbH
Orthopedic · 140d
Cleared Apr 11, 2016
Map-it Diagnostic Mapping Catheters
K160390 · DRF
Access Point Technologies Ep, Inc.
Cardiovascular · 60d
Cleared Apr 08, 2016
LifeCare PCA Infusion System
K143612 · MEA
Hospira, Inc.
General Hospital · 476d
Cleared Apr 08, 2016
Noris Medical Zygomatic Dental Implant System
K151909 · DZE
Noris Medical , Ltd.
Dental · 270d
Cleared Apr 08, 2016
MagView BIOMAGNETOMETER SYSTEM
K152184 · OLY
Tristan Technologies, Inc.
Neurology · 247d
Cleared Apr 08, 2016
Nihon Kohden Afib Detection Program QP-039P
K152305 · DSI
Nihon Kohden Corporation
Cardiovascular · 238d
Cleared Apr 08, 2016
PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM
K153063 · GEI
Teleflexmedical, Inc.
General & Plastic Surgery · 169d
Cleared Apr 08, 2016
Nephros S100
K153084 · NHV
Nephros, Inc.
Gastroenterology & Urology · 165d
Cleared Apr 08, 2016
KLOCKNER VEGA DENTAL IMPLANT SYSTEM
K153098 · DZE
SOADCO, S.L.
Dental · 165d
Cleared Apr 08, 2016
Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II
K153301 · KXT
Roche Diagnostics
Chemistry · 147d
Cleared Apr 08, 2016
EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear,...
K153305 · LPL
Eyeyon Medical
Ophthalmic · 144d
Cleared Apr 08, 2016
430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece,...
K153411 · EFB
Dentalez, Inc.
Dental · 135d
Cleared Apr 08, 2016
Philips Multislice CT System with Low Dose CT Lung Cancer
K153444 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 133d
Cleared Apr 08, 2016
OLYMPIC Posterior Spinal Fixation System
K153446 · OSH
Astura Medical
Orthopedic · 133d
Cleared Apr 08, 2016
FDR D-EVO flat Panel Detector System
K153464 · MQB
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 129d
Cleared Apr 08, 2016
Bladder Scanner
K153581 · IYO
Caresono Technology Co., Ltd.
Radiology · 115d
Cleared Apr 08, 2016
First Ray Internal Bone Staple System
K153622 · JDR
First Ray, LLC
Orthopedic · 112d
Cleared Apr 08, 2016
OneQ-SL s-Clean Implant System
K153639 · DZE
Dentis Co., Ltd.
Dental · 109d