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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
67369–67392 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 30, 2004
ATRILAZE SOFT TISSUE ABLATION SYSTEM
K040744 · GEX
Medical Cv, Inc.
General & Plastic Surgery · 252d
Cleared Nov 30, 2004
PUMP CONNECTIVITY INTERFACE
K040985 · FRN
Baxter Healthcare Corp
General Hospital · 229d
Cleared Nov 30, 2004
SURGICAL DRAPE KIT - D.I.R.R.A. SRL
K041080 · LRO
D.I.R.R.A. S.R.L.
General & Plastic Surgery · 218d
Cleared Nov 30, 2004
ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT
K041432 · HIS
Biofilm, Inc.
Obstetrics & Gynecology · 186d
Cleared Nov 30, 2004
GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS
K041501 · MMP
Guangzhou Fortunique , Ltd.
General Hospital · 176d
Cleared Nov 30, 2004
ENPATH SAFETY INTRODUCER
K041708 · DYB
Enpath Medical Incorporated
Cardiovascular · 160d
Cleared Nov 30, 2004
DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO A LED LITE HEAD
K042382 · FSY
Med-General Technologies, LLC
General & Plastic Surgery · 90d
Cleared Nov 30, 2004
VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I,...
K042520 · KLS
Ortho-Clinical Diagnostics, Inc.
Toxicology · 75d
Cleared Nov 30, 2004
OPTIV ANTAGE DH POWER INJECTION SYSTEM
K042744 · DXT
Mallinckrodt Inc., Liebel-Flarsheim...
Cardiovascular · 57d
Cleared Nov 30, 2004
VAG O SPECULUM, MODELS VS1, VM1, VL1
K042950 · HIB
Panatrex, Inc.
Obstetrics & Gynecology · 35d
Cleared Nov 30, 2004
ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM
K043196 · IYN
Aloka Co., Ltd.
Radiology · 12d
Cleared Nov 29, 2004
MB SYSTEM, BIOENERGY LIGHT THERAPY
K030275 · ILY
Amest Corp.
Physical Medicine · 672d
Cleared Nov 29, 2004
TRIAGE D-DIMER TEST, MODEL 98100
K042890 · GHH
Biosite Incorporated
Hematology · 41d
Cleared Nov 29, 2004
FIBROTEK FIB
K042919 · GIS
R2 Diagnostics, Inc.
Hematology · 38d
Cleared Nov 26, 2004
MEDTRADE PRODICT'S SOOTHING GEL PATCH
K030901 · NTC
Medtrade Products , Ltd.
General Hospital · 613d
Cleared Nov 26, 2004
EZY-TRAVEL WRISTBAND
K041766 · MVV
Apothecary Products, Inc.
Neurology · 149d
Cleared Nov 26, 2004
NEXUS INTRAVENOUS TUBING SETS (NIVTS)
K041861 · FPA
Nexus Medical, LLC
General Hospital · 140d
Cleared Nov 26, 2004
PRIMUS US
K042607 · BSZ
Draeger Medical, Inc.
Anesthesiology · 63d
Cleared Nov 26, 2004
LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE -...
K042618 · FMC
La Glove (M) Sdn. Bhd.
General Hospital · 60d
Cleared Nov 26, 2004
POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA, NATURAL WATER, SOLUBLE...
K042645 · LYY
Qingdao Bestex Rubber & Plastic...
General Hospital · 60d
Cleared Nov 26, 2004
PACK & PROPER PACK & PROPER, EAR-THERMOMETER PROBE CAP
K042653 · FLL
Pack & Proper Co., Ltd.
General Hospital · 59d
Cleared Nov 26, 2004
REUSABLE FINGER CLIP SPO2 SENSORS
K042704 · DQA
Elekon Industries U.S.A., Inc.
Anesthesiology · 57d
Cleared Nov 26, 2004
CLEARFIL TRI-S BOND
K042913 · KLE
Kuraray Medical, Inc.
Dental · 36d
Cleared Nov 26, 2004
SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE
K042936 · FPA
Baxter Healthcare Corp
General Hospital · 32d