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
31441–31464 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 04, 2016
RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters,...
K153209 · OMP
Smith & Nephew Medical, Ltd.
General & Plastic Surgery · 273d
Cleared Aug 04, 2016
Fehling-Punches
K153243 · HAE
Fehling Instruments GmbH & Co. KG
Neurology · 269d
Cleared Aug 04, 2016
Med-Tainer Single Deposit Container
K153274 · MMK
Snyder Industries, Inc.
General Hospital · 266d
Cleared Aug 04, 2016
MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis
K153329 · FIP
Med-Tech Water Systems, Inc.
Gastroenterology & Urology · 259d
Cleared Aug 04, 2016
Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators
K153540 · FRG
Safe Secure Packaging Co., Ltd.
General Hospital · 238d
Cleared Aug 04, 2016
OSSIX VOLUMAX
K153549 · NPL
Datum Dental, Ltd.
Dental · 237d
Cleared Aug 04, 2016
ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators,...
K153551 · NHX
Axis-Shield Diagnostics Limited
Immunology · 237d
Cleared Aug 04, 2016
A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content...
K153744 · LYY
A1 Glove Sdn Bhd
General Hospital · 220d
Cleared Aug 04, 2016
Microlyte Ag
K153756 · FRO
Imbed Biosciences, Inc.
General & Plastic Surgery · 218d
Cleared Aug 04, 2016
OSSIX PLUS
K160281 · NPL
Datum Dental, Ltd.
Dental · 184d
Cleared Aug 04, 2016
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and...
K160560 · LZA
Hartalega Sdn Bhd
General Hospital · 157d
Cleared Aug 04, 2016
Fully Automatic Electronic Blood Pressure Monitor
K160563 · DXN
Andon Health Co, Ltd.
Cardiovascular · 157d
Cleared Aug 04, 2016
Surveyor S4 Mobile Monitor
K160685 · MHX
Mortara Instrument, Inc.
Cardiovascular · 146d
Cleared Aug 04, 2016
Latex Powder Free Polymer Coated Examination Glove with Protein Labeling...
K161006 · LYY
Hartalega Sdn Bhd
General Hospital · 115d
Cleared Aug 04, 2016
IPL Therapy Machine
K161286 · ONF
Beijing Adss Development Co., Ltd.
General & Plastic Surgery · 87d
Cleared Aug 04, 2016
Mont Blanc and Mont Blanc MIS Spinal Systems
K161387 · NKB
Spineway SA
Orthopedic · 77d
Cleared Aug 04, 2016
FacetBRIDGE® System
K161798 · MRW
Ldr Spine USA, Inc.
Orthopedic · 35d
Cleared Aug 04, 2016
SIDEKICK and USHER Support Catheters
K161986 · DQY
Bard Peripheral Vascular, Inc.
Cardiovascular · 16d
Cleared Aug 03, 2016
A-Oss
K151542 · NPM
Hiossen, Inc.
Dental · 422d
Cleared Aug 03, 2016
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile,...
K151750 · LZA
Kossan International Sdn Bhd
General Hospital · 401d
Cleared Aug 03, 2016
IMMEDIATELOAD Dental Implant System
K151757 · DZE
Immediateload S.A.
Dental · 401d
Cleared Aug 03, 2016
Hilal Embolization MicroCoils
K160219 · KRD
Cook Incorporated
Cardiovascular · 187d
Cleared Aug 03, 2016
JointPoint
K160284 · LLZ
Jointpoint, Inc.
Radiology · 182d
Cleared Aug 03, 2016
iPEP System and vPEP
K160636 · BWF
D R Burton Healthcare, LLC
Anesthesiology · 149d